FAMCRU Completed Reseach Projects
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I MATERNAL?
A HIV
1) Therapeutic
(i) P1077
The 1077 protocol is designed to address in the integrated and comprehensive fashion.
4 critical questions currently facing HIV infected pregnant and postpartum women and their infants.
Duration: May 2011 to November 2016
Screened = 243 and Enrolled = 280
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT
?(ii) P1084
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir
Exposure: The Bone and Kidney Health Sub study of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)
Duration: May 2011 to January 2016
Screened = 70 and Enrolled = 35
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT
(iii) IMPAACT 2010
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants.
Duration: Jul 2018 to September 2019
Screened = 6 and Enrolled = 6
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
2) Prophylaxis
3) Cure
4) PMTCT
5) Other
(i) P1026
Pharmacokinetic properties of antiretroviral drugs during pregnancy
Duration: July 2014 to December 2019
Screened = 90 and Enrolled = 76
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT
(ii) P1031
The study evaluated the feasibility, rate of acceptance and acceptability of voluntary HIV counseling and rapid testing among pregnant woman with undocumented HIV serostatus who present for delivery and to compare intrapartum versus postpartum rapid testing with respect to these measures. Examined the rate of acceptance of an ability to administer antiretroviral prophylaxis prior to delivery to women who are identified as HIV seropositive through intrapartum rapid HIV testing and to their infants. Examined the rate of acceptance of and ability to administer antiretroviral prophylaxis to infants born to women who are identified as seropositive through postpartum rapid HIV testing.
Duration: October 2004 to September 2006
Screened = 7238; Eligible = 542 and Enrolled = 343
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT
(iii) Promotion of breastfeeding among women living with HIV
Project title: Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial.
Duration: May 2019 to August 2020
Screened = 123 and Enrolled = 52
Principle Investigator: Dr Moleen Zunza
Funder: Janssen/CTN Postdoctoral International Fellowship Award of the CIHR
Canadian HIV Trials Network, Stellenbosch 肆客足球 (reference no. SU-PT-16/09- 000054) and Harry Crossly Foundation.
(iv) Strategies to promote
Feasibility and effects of interactive weekly mobile phone text messaging plus motivational interviewing versus usual care in promotion of breastfeeding among women in South Africa living with HIV: A Pilot Randomized Controlled Trial
Duration: April 2019 to September 2020
Screened = 50 and Enrolled = 50
Principle Investigator: Dr Moleen Zunza
Funder: CIHR Canadian HIV Trials Network, Stellenbosch 肆客足球 (reference no.SU-PT-16/09- 000054) and Harry Crossly Foundation
B TB
1) Therapeutic
2) Prophylaxis
(i) P1078
A randomized double – blind placebo – controlled trial to evaluate the safety of immediate (antepartum – initiated) versus deferred (postpartum – initiated) isonaized preventive therapy among HIV – infected woman in high TB incidence settings.
Duration: January 2015 to June 2018
Screened = 126 and Enrolled = 149
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT
C Infectious diseases
1) RSV
(i) GSK Epi RSV 008
A prospective epidemiological study of women between 24-27 weeks of pregnancy to describe pregnancy outcomes and events of interest in the mother and neonate, as well as determine incidence in infants of RSV LRTI and RSV hospitalization.
Duration: July 2019 to December 2021
Screened = 168 and Enrolled = 164
Principle Investigator: Prof Mark Cotton
Funder: GlaxoSmithKline
(ii) RSV - M - 301
A phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminum in Healthy Third –trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in their Infants.
Duration: Jan 2016 – October 2019
Screened = 149 and Enrolled = 113
Principle Investigator: Prof Mark Cotton
Funder: Triclinium
2) Meningococcal
3) Group B Streptococcus
(i) GBS C1091006
Epidemiology of obstetric and neonatal outcomes in South Africa
Duration: May 2019 to August 2020
Screened = 1289 and Enrolled = 1289
Principle Investigator: Prof Shaun Barnabas
Funder: Pfizer
(ii) GBS 1002
A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Group B Streptococcus Vaccine in Healthy Non-pregnant Women and Pregnant Women 18 to 40 years of age and their Infants.
Duration: July 2019 to January 2020
Screened =155 and Enrolled =109 pairs
Principle Investigator: Prof Shaun Barnabas
Funder: Pfizer
D Other
(i) Novartis V98_15OB
A multicenter, observational study to identify factors that influence access of pregnant women and their infants to their local healthcare system.
Duration: 1February 2014 to December 2014
Screened = 294 and Enrolled = 294
Principle Investigator: Prof Mark Cotton
Funder: Novartis
(ii) Seroprevalence of Toxoplasma gondii infection in a mother- infant cohort in the Western Cape, South Africa
The Primary aim of the study is to document Toxoplasma gondii infection Seroprevalence in HIV (+) and HIV (-) mothers at the time of delivery and to identify acute infection or recent seroconversions. The secondary aim of the study is to document early Toxoplasma gondii infection in HIV exposed and HIV unexposed infants and establish seroprevalence patterns at 6 and 12 months respectively. Finally, the study also proposes to isolate the parasite from positive samples and characterize the strains via molecular and genetic analysis in order to inform on their virulence.
Duration 16 July 2012 to July 2014
Screened = 265 & Enrolled = 265
Principle Investigator: Kenneth Hammond – Aryee
Funder - MRC + DST-NRF
II PAEDIATRIC?
A HIV
1) Therapeutic
(i) Boehringer Ingelheim BI Trial No 1100-1368
A randomized open-labeled multi-center trial of the pharmacokinetics, efficacy, and safety of parameters of Nevirapine 4 or 7mg when administered in combination with ZDV and 3TC for 8 weeks in anti- retroviral na?ve pediatric patients.
Duration: Feb 2002 to Dec 2004
Screened = 66 and Enrolled = 42
Principle Investigator: Prof Mark Cotton
Funder: Boehringer Ingelheim
(ii) Boehringer Ingelheim Extended dose nevirapine
This study is looking at a formulation of nevirapine that only needs to be given once a day instead of twice as presently used. The correct dose, safety and efficacy of extended release nevirapine will be determined. Inclusion age criteria: ≥ 3 to ≤ 18 years
Duration May 2009 to December 2009
Screened = 10 and Enrolled = 4
Principle Investigator: Prof Mark Cotton
Funder: Boehringer Ingelheim
(iii) BMS Eva
An Open-Label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination with Didanosine and Emtricitabine in HIV-Infected Infants and Children 3 months to 6 years of Age.
Duration: 01 July 2010 - to July 2013
Screened = 7 and Enrolled = 3
Principle Investigator: Prof Mark Cotton
Funder: Bristol Myers Squibb
(iv) BMS Prince I
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with Optimal an optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study).
Duration: 1February 2011 to February 2018
Screened = 25 and Enrolled = 15
Principle Investigator: Prof Mark Cotton
Funder: Bristol Myers Squibb
(v) BMS – Prince II
A Prospective Single Arm, Open-label, International, Multicentre Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral, Naive and Experienced Pedriatric Subjects Greater Than or Equal to 3 Months to Less Than 8 Years
Pediatric Atazanavir International Clinical Evaluation: the PRINCE II study).
Duration: 1 November 2011 to February 2018
Screened = 38 and Enrolled = 24
Principle Investigator: Prof Mark Cotton
Funder: Bristol Myers Squibb
(vi) BMS Prince III
Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years.
Duration: 1February 2014 to March 2018
Screened = 5 and Enrolled = 5
Principle Investigator: Prof Mark Cotton
Funder: Bristol Myers Squibb
(vii) Gilead 311 – 1269
A Phase 1/2, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2 NRTI Containing Regimen
Duration: January 2016 to November 2022
Screened = 4 and Enrolled = 4
Principle Investigator: Prof Mark Cotton
Funder: GlaxoSmithKline
(viii) GSK APV 20002
A 48 Week Phase II, Open-label, 2 cohorts, multi-centre study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected Protease Inhibitor (PI) Na?ve and PI – experienced pediatric subjects aged 4weeks to < 2 years.
Duration: January 2016 to November 2020
Screened = 28 and Enrolled = 23
Principle Investigator: Prof Mark Cotton
Funder: GlaxoSmithKline
(ix) GSK APV 29005
A 48-week, Phase II, Non-Comparative, Open – Label, Multi-Cohort, multi-center Study to evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir BID when administered to HIV-1 infected, PI-na?ve and experienced. Pediatric subjects 2 to <6 years old.
Duration: August 2008 – July 2013 Close
Screened = 25 and Enrolled = 5
Principle Investigator: Prof Mark Cotton
Funder: GlaxoSmithKline
(x) Penta 17
A two-arm, Phase 2/3 multicentre, open-label, randomized study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to elvitegravir EVG) administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.
Duration: Aug 2016 + to September 2021
Screened = 25 and Enrolled = 20
Principle Investigator: Prof Mark Cotton
Funder: Penta
(xi) Penta 20 Odyssey
A randomized trial of dolutegravir (DTG) – based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first – line or switching to second – line ART.
Duration: Aug 2016 to 31 July 2023
Screened = 35 and Enrolled = 31
Principle Investigator: Prof Mark Cotton
Funder: Penta
(xii)Triangle Pharmacy MKC- 442
An open – labeled study of MKC – 442 in combination with nucleoside reverse transcriptase inhibitors in HIV-1 infected pediatric patients to evaluate its pharmacokinetics, preliminary safety and antiviral efficacy.
Duration: January 1999 to 2001.
Principle Investigator: Prof Mark Cotton
Enrolled = 13 patients
Funder: Triangle Pharmacy
Study Monitor: Quintiles Clindepharm.
(xiii) TMC114 – C212
A phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC/RTV b.i.d in treatment-experienced HIV-1 infected children and adolescents.
Duration: Sep. 2006 to April 2010
Screened = 5 and Enrolled = 1
Principle Investigator: Prof Mark Cotton
Funder: Tibotec Pharmaceuticals
(xiv) Intracellular concentrations of stavudine-triphosphate after administration of half-dose stavudine in children and adults Children on ART
This study will check whether the children have the same amount of stavudine inside their blood cells as the adults do when taking half the original standard dose. If they do then we can be confident that the low dose will fight HIV in children as well as it does in adults, allowing the recommended children's dose to be reduced. Using a smaller dose of stavudine will substantially reduce the frequency and severity of side effects, making the drug much safer for children in the developing world to use.
Duration: January 2014 to December 2015
Screened = 52 Enrolled = 40
Principle Investigator: Prof Steve Innes
Funder – Bill & Melinda Gates Foundation Global Health Research Grant.
(xv) Secure the future Apoptosis study
An evaluation of CD4+T cell apoptosis as a surrogate marker for monitoring progression and response to antiretroviral therapy in HIV-1 infected children – a single centre study.
Duration: June 2002 to 2005
Screened = 23 and Enrolled = 23
Principle Investigator: Prof Mark Cotton
Funder: Secure the Future
(xvi) P1060
This is a study comparing the response to 2 ARV regimes of HIV infected infants who have and have not previously received a single dose of Nevirapine for the prevention of mother – to – child – transmission.
Duration: November 2008 to December 2016
Screened = 130 and Enrolled = 89
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xvii) P1066
P1066 is a study looking at a new antiretroviral agent, Raltegravir which is an integrase inhibitor which works by blocking integrase, a protein that HIV needs to enter human cells and make more copies of it. The study will look at the correct dose to give to infants and children and will also look at the safety and efficacy of Raltegravir. Inclusion age criteria: 4 weeks to < 6 years.
Duration: July 2010 to April 2015
Screened = 5 and Enrolled = 2
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xviii) P1070
P1070 is a study looking at using an antiretroviral called efavirenz in children less than 3 years of age. Efavirenz is a type of antiretroviral known as a non-nucleoside reverse transcription inhibitor (NNRTI). It is presently not registered for use in children < 3 years. This study will look at the correct dose needed in infants and children and will also look at the safety and efficacy of efavirenz. It is also looking at giving efavirenz to children who need TB treatment in addition to ARVs. Inclusion age criteria: ≥ 3 months to ≤ 3 years.
Duration: 16 March 2010 to March 2016
Screened = 200 and Enrolled = 17
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xix) P1083
A Phase II / III trial of Lopinavir / Ritonavir dose according to the WHO Pediatric Weight band dosing guidelines.
Duration: 7 Mei 2012 to 31 October 2013
Screened 19 = and Enrolled = 13
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT
(xx) P1093
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Duration: July 2014 to February 2023
Screened = 13 and Enrolled = 6
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xxi) P1101
Phase I/II dose finding study to determine the safety, tolerance, drug-drug interaction and pharmacokinetics of Raltegravir containing antiretroviral therapy (ART) regimen in ART-Na?ve HIV-Infected and TB Co-infected children > 3 years to < 12 years of age.
Duration: October 2014 to November 2020
Screened = 20 and Enrolled = 11
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xxii) P1110
A Phase I Trial to evaluate the safety and Pharmacokinetics of Raltegravir in HIV-1-exposed neonates at high risk of acquiring HIV-1 infection.
Duration: February 2016 to February 2020
Screened = 1 & Enrolled 1
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xxiii) P1112
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and
pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS and VRC07-23LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1 Exposed Infants
Duration: January 2016 to December 2021
Screened = 71 & Enrolled 61
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xxiv) IMPAACT P1090
A Phase I/II, Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV)Treatment-Experienced HIV-1 Infected Infants and Children, aged ≥ 2 Months to < 6 Years.
Duration: Aug 2016 to November 2017
Screened = 0 and Enrolled = 0
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xxv) IMPAACT 2019
Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Abacavir /
Dolutegravir /Lamivudine Dispersible and Immediate Release Tablets in HIV-1
infected Children Less than 12 Years of Age.
Duration: November 2020 to May 2022
Screened = 19 and Enrolled = 6
Funder: IMPAACT
(xxvi) Cipra Project 2 (CHER) Trial
A Phase III, Randomized, Open-label trial to evaluate strategies for proving antiretroviral therapy to infants shortly after primary infection in a resource poor setting.
Duration: August 2005 to August 2011
Screened = 3610 and Enrolled = 136
Principle Investigator: Prof Mark Cotton
Funder: CIPRA
2) Prophylaxis
(i) Rockefeller
Standard Strategies for prevention of opportunistic infection in HIV infected SA children. Comparison of two Bactrim prophylaxis regimes with and without INH impact on morbidity, mortality, incidence of TB and bacterial resistance.
Duration KIDCRU: 12 December 2002 to 15 September 2004
Screened = 164 and Enrolled = 164
HAART Phase
Duration KIDCRU: March 2009 to October 2011
Screened = 27 – Enrolled = 19
Duration Paarl: July 2007 – October 2011
Screened = 45 – Enrolled = 32
Principle Investigator: Prof Mark Cotton
Funder – Rockefeller Foundation + MRC.
(ii) Study 35
Phase I/II Dose finding and safety study of Rifaentine and Isoniazid in HIV-
Infected and HIV-Uninfected children with latent tuberculosis infection.
Duration: November 2021 to January 2024
Screened = 21 and Enrolled = 12
Principle Investigator: Prof Shaun Barnabas
Funder: CDC
3) Cure
(i) HIV Cure
Investigating the optimal age for early infant diagnosis of HIV in order to prevent HIV- associated disease and mortality.
Duration: April 2018 to May 2018
Principle Investigator: Prof Mark Cotton
Screened = 51 and Enrolled = 51
Funder: NIH
B HIV/TB epidemiology / observational / PK
(i) Secure the future: 6 versus 9 months.
Randomized clinical trial to evaluate the optimal duration of TB chemotherapy in Human Immunodeficiency Virus infected in children with TB and to assess the effect of TB on the natural history of Human Immunodeficiency Virus infection.
Duration: November 2002 to January 2006
Screened = 400 and Enrolled = 50
Principle Investigator: Prof Mark Cotton
Funder Bristol Myers Squibb
(ii) DNDiHIVPed001
The study is looking at the drug levels of anti-HIV/TB in the blood of children that are Co infected with HIV and TB. It also looks at the safety and how children tolerate the Anti-HIV/TB drugs while they are on treatment. For the study children need to weigh Between 3 kg and 15 kg.
Duration: January 2013 to July 2016
Screened = 60; Enrolled = 45
Principle Investigator: Prof Mark Cotton
Funder – DNDI
(iii) DATIC: Optimal dosing of 1st line anti tuberculosis and antiretroviral drugs in children (a pharmacokinetic study) DATiC study
Duration: October 2015 to November 2017
Screened = 5 and Enrolled = 5
Principle Investigator: Prof Anneke Hesseling
Funder: DATIC
(iv) Isoniazid preventive therapy
Tuberculosis is a common cause of mortality and morbidity in HIV-infected children. This study assessed the efficacy, tolerability, and safety of long-term isoniazid Preventive therapy in HIV-infected children on antiretroviral therapy and found it to be safe and well tolerated.
Enrolment between May 2005 and Oct 2009; Follow-up until Nov 2011
Screened = 325; Enrolled = 167
Principle Investigator: Prof Steve Innes
Funders: Medical Research Council, South Africa; National Research Foundation, South Africa; Department of Health, South Africa; Discovery Foundation.
(v) IDC Lipodystrophy study
Prospective observational study to determine the prevalence of lipodystrophy among children at the Family Clinic for HIV at Tygerberg.
Duration: January 2010 to June 2012
Screened = 163 and Enrolled = 157
Principle Investigator: Prof Steve Innes
Funder - Fogarty International Clinical Research Fellowship + The 肆客足球 of
California San Diego Centre for AIDS Research + Welcome Trust via the Southern Africa Consortium for Research Excellence (SACORE).
(vi) Lipoatrophy screening tool validation study
This study aims to validate the various simple anthropometric measurements to
Screen for pre-clinical lipoatrophy in children on ART, including biceps skin-fold
thickness.
Duration: January 2013 to September 2020
Screened = 230 Enrolled = 214
Principle Investigator: Prof Steve Innes
Funder – GSK-Viiv Foundation Seed Fund
(vii) Lipoatrophy screening tool study
This study aimed to investigate the possibility of using simple anthropometric
measurements to screen for pre-clinical lipoatrophy in children on ART. Biceps skin-old thickness was found to perform best with sensitivity and specificity of 89% and 60% respectively.
Duration: January 2010 to June 2012
Screened = 163 and Enrolled = 157
Principle Investigator: Prof Steve Innes
Funder - Fogarty International Clinical Research Fellowship + The 肆客足球 of
California San Diego Centre for AIDS Research + Wellcome Trust via the Southern Africa Consortium for Research Excellence (SACORE).
(viii) MIHS
Prospective cohort study to determine whether in utero HIV exposure is associated with an increased risk of infectious morbidity in HIV exposed uninfected infants; whether there is a difference in severity of infectious morbidity between HIV exposed uninfected and HIV unexposed uninfected infants; and whether the extent of maternal HIV disease is associated with severity of infectious morbidity. Within the cohort, sub- studies will address infant feeding choices, placental pathology and immunology, CMV incidence and infection and toxoplasmosis incidence and infection.
Duration 16 July 2012 to December 2014
Screened = 265; Enrolled = 265
Principle Investigator: Prof Mark Cotton
Funder - The 肆客足球 of British Columbia
(ix) Non-infectious Chronic Diseases in Children on ART
This study aims to identify the most common and clinically relevant non-infectious chronic disease patterns (cardiovascular, metabolic, respiratory, renal and bone disease) in HIV-infected children on ART.
Duration: July 2013 to September 2020
Screened & Enrolled = 135
Principle Investigator: Prof Steve Innes
Funder – Collaborative Initiative for Paediatric HIV Education and Research
(CIPHER), Fogarty International Clinical Research Fellowship + The 肆客足球 of California San Diego Centre for AIDS Research
(x) P1041 Sub study (DACS 646)
Predictors of TB disease in HIV exposed uninfected and HIV infected children within P1041. This sub analysis is looking at predictions of TB disease such as the impact of passive smoking in developing TB disease in children exposed and infected with HIV.
Duration: March 2009 to May 2010
Enrolled = 220
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xi) P1041
A randomized, double blind, placebo-controlled trial to determine the efficacy of
Isoniazid (INH) in preventing Tuberculosis disease and latent Tuberculosis
Infection among South African infants with perinatal exposure to HIV.
Duration: Feb 2004 to June 2008
Screened = 913 and Enrolled = 412
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xii) P1106
Pharmacokinetic characteristics of antiretroviral and tuberculosis medicines in low-birth-weight infants.
Duration: July 2015 to March
Screened = 119 Enrolled: 78
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(xiii) Cipra BCG substudy
This study investigated the rate and severity of BCG immune reconstitution adenitis in HIV-infected infants randomized to early or deferred antiretroviral therapy. It was found that early antiretroviral therapy substantially reduces the risk of this condition.
Duration May 2005 to December 2008
Screened = 377; Enrolled = 369
Principle Investigator: Prof Helena Rabie
Funder - US National Institute of Allergy and Infectious Diseases (NIAID)
(xiv) Reservoir
Latent reservoir characterization and correlations with neurocognitive function.
Duration: November 2014 to December 2019
Screened = 358 and Enrolled = 358
Principle Investigator: Prof Mark Cotton
Principle Investigator: Prof Mark Cotton
Funder: NIH
(xv) Collaborative HIV Paediatric Study (CHIPS) subanalysis
The study database is from a multicentre cohort study of all known HIV-infected children in the United Kingdom (UK). This subanalysis looks at the prevalence and risk factors for lipoatrophy and lipohypertrophy in this cohort over 12 years.
Duration: March 2013 – July 2022
Screened = 1791; Enrolled = 1350
Principle Investigator: Prof Steve Innes
Funder – None
C TB
1) Therapeutic
2) Prophylaxis
(i) P1113
Phase I/II, safety immunogenicity study of a recombinant protein tuberculosis vaccine (AERAS-404) IN BCG-primed infants
Duration: July 2013 to 2015
Screened = 97 and Enrolled = 46
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT/ AERAS
D Infectious diseases
1) Respiratory Syncytial Virus – RSV
(i) Medimmune I
A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody with an Extended Half-Life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Duration: July 2015 to Dec 2016
Screened = 58 and Enrolled = 41
Principle Investigator: Prof Mark Cotton
Funder: Medimmune
(ii) Medimmune 2
A Phase 1b/2a randomized, double-blind, placebo-controlled, dose-escalation.
study to evaluate the safety, tolerability, and Pharmacokinetics of MEDI8897, a
Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial
Virus, in healthy preterm infants.
Duration: Jan 2016 to March 2018
Screened = 63 and Enrolled = 42
Principle Investigator: Prof Mark Cotton
Funder: Medimmune
(iii) Medimmune Medley
Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to
evaluate the Safety of MEDI8897, a Monoclonal Antibody with an Extended
Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
Duration: Jan 2020 to March 2021
Screened = 10 and Enrolled = 8
Principle Investigator: Prof Mark Cotton
Funder: Medimmune
(iv) Medimmune Melody
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate
The Safety and Efficacy of MED18897, a Monoclonal Antibody With an
extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm
and Term Infants (MELODY).
Duration: Jan 2020 to January 2022
Screened = 53 and Enrolled = 43
Principle Investigator: Prof Mark Cotton
Funder: Medimmune
(v) MSD MK 1654 002
A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in
pre-Term and Full-Term Infants
Duration: March 2019 to May 2022
Screened = 11 and Enrolled = 11
Principle Investigator: Prof Shaun Barnabas
Funder: MSD
(vi) Novavax RSV-M-301 season 1
A phase 3, Randomized, observer – blind, Placebo – controlled, group
Sequential study to determine the immunogenicity and safety of a respiratory
syncytial virus (RSV) F Nanoparticle vaccine with aluminum in healthy third –
trimester pregnant woman: and safety and efficacy of maternally transferred
antibodies in preventing RSV disease in their infants.
Duration: January 2016 to March 2017
Screened = 26 and Enrolled = 21
Principle Investigator: Prof Mark Cotton
Funder: Novavax
(v) Novavax season 2
A phase 3, Randomized, observer – blind, Placebo – controlled, group
Sequential study to determine the immunogenicity and safety of a respiratory
syncytial virus (RSV) F Nanoparticle vaccine with aluminum in healthy third –
trimester pregnant woman: and safety and efficacy of maternally
transferred antibodies in preventing RSV disease in their infants.
Duration: December 2016 to May 2018
Screened = 123 and Enrolled = 95
Principle Investigator: Prof Mark Cotton
Funder: Novavax
(vi) Novavax season 3 – J8
A phase 3, Randomized, observer – blind, Placebo – controlled, group
Sequential study to determine the immunogenicity and safety of a respiratory
syncytial virus (RSV) F Nanoparticle vaccine with aluminum in healthy third –
trimester pregnant woman: and safety and efficacy of maternally transferred
antibodies in preventing RSV disease in their infants.
Duration: August 2018 to July 2019
Screened = 229 and Enrolled = 186
Principle Investigator: Prof Mark Cotton
Funder: Novavax
(vii) Novavax season 3 Worcester
RSV-M-301 A Phase 3, randomized, observer – blind, placebo controlled,
Group Sequential study to determine the immunogenicity and safety of a
Respiratory Syncytial Virus (RSV) F Nanoparticle vaccine with aluminum in
heathy third – trimester pregnant woman, and safety and efficacy of maternally
transferred antibodies in preventing RSV disease in their infants.
Duration: August 2018 to July 2019
Screened = 90 and Enrolled = 76
Principle Investigator: Prof Mark Cotton
Funder: Novavax
(viii) Med 55
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal
Conjugate Vaccine in Healthy Adults, Adolescents, and Children in India and Healthy Adolescents and Children in the Republic of South Africa
Duration: January 2020 to December 2020
Screened = 71 and Enrolled = 69
Principle Investigator: Prof Mark Cotton
Funder: Sanofi Pasteur
2) Pneumococcus
(i) MSD MK V114 030
A Phase 3, Multicenter, Randomized, Double‐blind, Active Comparator
Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of
V114 Followed by Administration of PNEUMOVAX?23 Eight Weeks Later in
Children Infected with Human Immunodeficiency Virus (HIV) (PNEU–WAY
PED)
Duration: February 2020 to August 2021
Screened = 86 and Enrolled = 71
Principle Investigator: Prof Shaun Barnabas
Funder: MSD
(ii) Cipra Project 4 trial
An Evaluation of quantitative and qualitative antibody response to treptococcus
pneumonia and Haemophilus Influenza Type b conjugate vaccines amongst
HIV-1 –exposed – infected children that are receiving vs. those not receiving
antiretroviral therapy, as well as among HIV-1 unexposed – uninfected
children.
Duration: May 2005 to August 2011
Screened = 3599 and Enrolled = 193
Principle Investigator: Prof Mark Cotton
Funder: CIPRA
3) Rotavirus
(i) VAC041
A Phase I/II double-blind, randomized, placebo-controlled, descending-age,
dose-scalation study to examine the safety, tolerability and immunogenicity of
the trivalent P2-VP8 subunit rotavirus vaccine in healthy South African adults,
toddlers and infants.
Duration: Nov 2016 to Jan 2018
Screened = 174 and Enrolled = 136
Principle Investigator: Prof Mark Cotton
Funder: VAC
E Neurodevelopment
(i) Healthy Babies Neonatal imaging as an early marker of neurodevelopment and predictor of cognitive performance in infants exposed to HIV and ART in utero and postnatally
Duration: June 2017 to September 2021
Screened = 330 and Enrolled = 323
Principle Investigator: Prof Barbara Laughton
Funder: Massachusetts General Hospital (sub-NIH)
(ii) Early neurodevelopmental outcome of HIV – Exposed but uninfected
Infants in Cape Town, South Africa.
Duration: July 2013 to July 2014
Screened: 87 Enrolled: 87
Principle Investigator: Dr Pricilla Springer
Funder: Harry Crossley
(iii) P1104
Longitudinal Developmental and Neuropsychological Assessments of HIV-
infected participants of P1060 and HIV- Uninfected Controls
Duration: 25 October 2013 to December 2016
Screened = 161 and Enrolled = 142
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(iv) R01 + R21
The effects of early versus delayed antiretroviral treatment on the short and
long – Term neurodevelopment outcome of HIV – Infected children.
Duration: September 2011 to September 2016
Screened & Enrolled = 187
Principle Investigator: Prof Barbara Laughton
Funder: Massachusetts General Hospital
(v) Cipra Substudy
Association of Maternal Depression and Other Psychiatric Outcomes with
Long-term Neurodevelopment in HIV – Positive Infants Receiving Early or
Delayed Antiretroviral Treatment
Duration: January 2006 to June 2012
Enrolled = 180
Principle Investigator: Dr Sumaiya Sidat
Funder: MRC
(vi) Cipra Neurodevelopmental Substudy
The effects of early versus delayed antiretroviral treatment on the short and
long – Term neurodevelopment outcome of HIV – Infected children in HIV
positive Infants Receiving Early or Delayed Antiretroviral Treatment
Duration: January 2006 to June 2012
Enrolled = 180
Principle Investigator: Prof Barbara Laughton
Funder: MRC
F Other
(i) Iron
A novel stable iron isotope method to define iron needs and improve iron
nutrition in HIV+ and HIV- children.
Duration: October 2018 to September 2022
Screened = 305 Enrolled = 180
Principle Investigator: Prof Renee Blaauw
Funder – The Thrasher foundation
(ii) Feasibility study
Feasibility study of a powder-based placebo in children
Duration: May 2021 to July 2021
Screened = 10 Enrolled =10
Principle Investigator: Prof Barbara Laughton
Funder: Columbia 肆客足球
(iii) P 369
A phase I/II open label study of Nitazoxanide for the treatment of
Cryptosporidium Parvum in HIV infected infants, children and adolescents.
Duration: January 2004 to June 2005
Principle Investigator: Prof Mark Cotton
Screened = 10 and Enrolled = 3
Principle Investigator: Prof Mark Cotton
Funder: PACTG
(iv) P1073
P1073 is a study looking at a condition called Immune Reconstitution
Inflammatory Syndrome (IRIS). IRIS can be seen shortly after starting ARVs
and it happens when the immune system recovers too quickly resulting in
inflammation. This inflammation can cause severe symptoms that could be
mistaken for an HIV-associated illness. The IRIS study will specifically be
looking at inflammation associated with prior or present undetected BCG and or
TB disease. Inclusion criteria: Infants and children ≥ 4 weeks - ≤ 5 years who
are about to initiate ARVs.
Duration: 2 February 2010 to August 2013
Screened = 231 and Enrolled = 80
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
(v) MSD
A Multicenter, randomized, double – blind, double – dummy, parallel – group
study evaluating the effects of 2 different regiments of Montelukast (Daily
dosing and intermittent, episode driven dosing) compared with placebo in the
treatment of episodic asthma in children aged 2 to 5 years.
Duration: March 2006 to March 2007
Screened = 6 and Enrolled = 4
Principle Investigator: Prof Mark Cotton
Funder: MSD
(vi) Cytomegalovirus sub-study
The primary aim of the sub-study is to determine the incidence and timing of
CMV infection in HIV-exposed and HIV-unexposed babies. Secondary aims are
To determine the source of infection and to determine whether CMV infection
Increases the risk of HIV or other clinical infections in HIV.
Duration 16 July 2012 to July 2014
Screened = 265; Enrolled = 255
Principle Investigator: Dr Monique Anderson
Funder – NHLS Research Trust + Polio Research Foundation
G HEU
(i) Father involvement in the care infants of HIV-exposed uninfected and
HIV- unexposed infants
In this study we aim to determine first, what care giving, economic provisioning
And decision-making roles are being performed by the fathers of a cohort of
South African infants: and second, whether maternal HIV-infection influences
the dominant roles these fathers adopt. In so doing, we hope to contribute to
the limited body of knowledge of the ways in which fathers are involved in
caring for their young children in African families, particularly those affected by
HIV infection.
Duration 16 July 2012 to July 2014
Screened = 243; Enrolled = 100
Principle Investigator: Gareth Mercer
Funder – Children's and Women's Health Centre of British Columbia
(ii) HEU
HIV Exposed Uninfected (HEU) Infants have a transient innate immune
abnormality and a possible adaptive immune difference. Pilot study: to
investigate the innate Immune response in HEU and HIV unexposed (UE)
infants at 2 and 6 weeks and Adaptive immune response at 12 weeks of life.
Objectives (1) determine the difference between HEU and UE infants in innate
immune function. (2) To determine the significance of this difference. (3)
determine vaccine responses to standard vaccines.
Duration March 2009 to August 2011
Screened 180 and Enrolled = 96
Principle Investigator: Monika Esser
Funder - The 肆客足球 of British Columbia
(iii) HIV Specific Cell Mediated Immunity in South African HIV Exposed
Uninfected (HEU) Infants
Primary Study Aim: Assess CD4 and CD8 T cell responses to HIV viral
Peptides subsequent to Treg depletion, in HIV Exposed Uninfected (HEU)
infants at 6 and 12 months.
Duration 16 July 2012 to July 2014
Screened = 265; Enrolled = 265
Principle Investigator: Dr Monica Esser
Funder – NHLS Trust Grant
(iv) Outcomes of different feeding regimens in a birth cohort of HIV-
exposed infants in public healthcare settings
This sub-study seeks to determine whether there is a difference in the health
Outcomes of HIV-exposed infants intended to be breast fed (with ARV
prophylaxis), HIV-exposed infants intended to receive free infant formula milk
for the first 6 months of life, and HIV- unexposed infants intended to be breast
fed from birth until 1 year of age. In addition, we will identify the clinical and
growth outcomes of formula-fed HIV- exposed infants between 6 and 12
months of age after free infant formula supply has been stopped.
Duration 16 July 2012 to December 2014
Screened = 315; Enrolled = 315
Principle Investigator: Moleen Zunza
Funder – Harry Crossley + NRF + Bursary
(v) Study of hematological parameters and large unstained cell (LUC)
values in South African HIV exposed uninfected (HEU) infants and
Haylie Ipp. Primary Study Aim: To describe hematological parameters and
large unstained cell (LUC) values in South African HEU infants. Secondary
study Aims: To determine levels of immune activation in these groups of
infants and correlate these levels with LUCs and other full blood count
parameters.
Duration 16 July 2012 to July 2014
Screened = 265; Enrolled = 265
Principle Investigator: Janami Steenkamp
Funder – NHLS K Fund, NHLS Trust Grant application
(vi) The association between placental histopathological and
Immunological Features and clinical and immunological outcomes in HIV
exposed uninfected infants.
The aim of his sub-study is to describe the proportion of HIV-infected women
and HIV- infected women in the study population who demonstrate placental
abnormalities on histopathologic examination, whether any of the
histopathologic abnormalities identified are associated with differences in levels
of circulating CD4+ T lymphocytes and/or HIV viral load at delivery or duration
of ART, and to determine the levels of CD4+CD25+ regulatory cells (Tregs) in
the placenta. In addition, we hope to characterize the maternal lymphocyte
populations involved in any cases of chronic villitis identified among the HIV-
Infected and HIV-uninfected women in our study sample.
Duration 16 July 2012 to July 2014
Screened = 25; Enrolled = 22
Principle Investigator: Dr Emma Kalk
Funder – Harry Crossley + The 肆客足球 of British Columbia
III ADOLESCENT
A HIV
1) Therapeutic
(i) Gilead 236-0112 (QUAD Study) A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV- Infected Antiretroviral Treatment-Naive Adolescents Treatment-Naive Adolescents.
Duration: July 2014 to November 2023
Screened = 4 and Enrolled = 1
Principle Investigator: Prof Mark Cotton
Funder: Gilead
2) Cure
B Neurocognitive
(i) Neuropsychiatric substudy
The impact of long-term antiretroviral treatment on neuropsychiatric outcomes in South African children perinatal infected with the human immune deficiency virus (HIV). Short title of the sub-study: Reservoir Neuropsychiatry Study
Duration: February 2019 to March 2021
Screened: 91 & Enrolled: 91
Principle Investigator: Dr Renee Nassen
Funder: NRF
C Other
(i) ATN 024 I
A randomized, open-label trial of Three Hepatitis B vaccination schemas in HIV- Positive Youth for International Sites.
Duration: 2006 to 2007
Screened = 8 and Enrolled = 5
Principle Investigator: Prof Mark Cotton
Funder: ACTG
(ii) Arch
Auditory Research in Children with HIV: Cape Town. Study Acronym: ARCH: Cape Town
Duration: September 2018 to December 2021
Screened 241 & Enrolled = 241
Principle Investigator: Prof Barbara Laughton
Funder: San Diego State 肆客足球
IV Adult
A HIV
(i) AMC 098
A Pilot Study of Nelfinavir for the Treatment of Kaposi Sarcoma
Duration: March 2021 to January 2022
Principle Investigator: Dr Henriette Burger
Screened = 241 and Enrolled = 241
Funder: UCLA
(ii) BMS A1438-047
A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1
Duration: Jan 2016 to July 2016
Screened = 2 and Enrolled = 0
Principle Investigator: Dr Marije van Schalkwyk
Funder: BMS
(iii) GSK Ing 117175 INSPRING
A Phase III b, randomized, open-label study of the safety and efficacy of dolutegravir or efavirenz each administered with two NRTIs in HIV-1-infected antiretroviral therapy- na?ve adults starting treatment for rifampicin-sensitive tuberculosis.
Duration: March 2016 to August 2020
Screened = 5 and Enrolled = 5
Principle Investigator: Prof Jantjie Taljaard
Funder: GlaxoSmithKline
(iv) GSK 20809 Salsa
A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressed.
Duration: January 2020 to November 2022
Screened = 13 and Enrolled = 3
Principle Investigator: Dr Marije van Schalkwyk
Funder: GlaxoSmithKline
(v) GSK Dynamic
A Phase IIb, randomized, double-blind, parallel-group study to assess the efficacy, safety, tolerability, and resistance profile of GSK3640254 in combination with dolutegravir compared to dolutegravir plus lamivudine in HIV-1 infected, treatment na?ve adults.
Duration: December 2021 to May 2022
Screened = 2 and Enrolled = 0
Principle Investigator: Dr Marije van Schalkwyk
Funder: GlaxoSmithKline
(vi) Stavudine Adult Bioequivalence study
Randomized cross- over pharmacokinetic study to compare the bioavailability
of opened vs. intact generic stavudine capsules.
Duration: 26 July 2008 to 16 August 2008
Screened = 28 and Enrolled = 28
Principle Investigator: Prof Steve Innes
Funder: South African National Department of Health Research Reference Committee
(v) A5263
A Randomized Comparison of Three Regimens of Chemotherapy with
Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in
Resource-Limited Settings.
Duration: August 2016 to February 2020
Screened = 4 & Enrolled 3
Principle Investigator: Dr Henriette Burger
Funder: ACTG
vi) A5264
A Randomized Evaluation of Antiretroviral Therapy alone or with Delayed
Chemotherapy versus Antiretroviral Therapy with Adjunctive Chemotherapy for
Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS).
Duration: February 2016 to March 2016
Screened = 0 & Enrolled 0
Principle Investigator: Prof Jantjie Taljaard
Funder: ACTG
(vii) A5278s
Pharmacology sub studies of A5263 and A5264
Duration: August 2016 to November 2019
Screened = 1 & Enrolled 1
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
(viii) A5288
Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral failure (MULTI-OCTAVE)
Duration: June 2015
Screened = 27and Enrolled = 20
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
(ix) A5290
A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based
Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a
Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with ifabutin-
Based Tuberculosis Treatment with or without Raltegravir in HIV-1-Infected
Persons Requiring Treatment for Active TB and HIV
Duration: August 2018 to November 2019
Screened 0 and Enrolled = 0
Principle Investigator: Dr Jantjie Taljaard
Funder: ACTG
(x) A5324
A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV.
Duration: October 2020 to November 2021
Screened = 2 & Enrolled 2
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
(xi) A5332
Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE Final
Version 3.0 January 28, 2016
Duration: Nov 2016 to July 2023
Screened = 44 and Enrolled = 36
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
(xii) A5354
Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on
Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
Duration: August 2018 to November 2019
Screened = 0 and Enrolled = 0
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
(xiii) A5381
Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART or with Rifampicin-Containing TB Treatment
Duration: January 2020 to May 2023
Screened = 46 & Enrolled 46
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
(xiv) Pharmacokinetic drug interaction study of metformin and dolutegravir
Duration: March 2024 to December 2024
Screened = 15 & Enrolled 15
Principle Investigator: Dr Roland van Rensburg
Funder: Harry Crossley Foundation & Fogarty International Center of the National Institutes of Health under Award Number D43TW010937
?B COVID
1)Vaccine
(i) ChAdox
An adaptive Phase I/II randomized, placebo-controlled trial to determine safety,
immunogenicity and efficacy of non-replicating ChAdOx1 SARS-CoV-2 vaccine in South African adults living without HIV; and safety and immunogenicity in adults living with HIV.
Duration: August 2020 to November 2021
Screened = 213 and Enrolled = 213
Principle Investigator: Prof Shaun Barnabas
Funder: Wits Vaccine and Infectious Diseases Analytics unit (Wits – VIDA)
(ii) Crown
CROWN CORONATION, an international, multi-site, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate agents in mitigating COVID-19 disease in healthcare workers.
Duration: March 2021 to December 2021
Screened = 181 and Enrolled = 104
Principle Investigator: Dr Shaun Barnabas
Funder: Washington 肆客足球 School of Medicine
(iii) Sisonke
SISONKE 1: Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa (VAC31518COV3012)
Duration: February 2021 to May 2021
Screened = and Enrolled = 16,534
Principle Investigator: Prof Shaun Barnabas
Funder: MRC
(iv) SISONKE 2 (BOOST):
Open-label, single-arm phase 3B implementation study To evaluate the effectiveness of the homologous boost of Ad26.COV2.S COVID-19 vaccine following the prime dose among Sisonke participants in South Africa (VAC31518COV30XX)
Duration: November 2022 to December 2022
Screened 0 = and Enrolled = 0
Principle Investigator: Prof Shaun Barnabas
Funder: MRC
(v) SISONKE 4 (SHERPA):
Open-label, phase 3 study to evaluate the effectiveness of heterologous mRNA-1273 boosting of the single or two dose Ad26.COV2.S COVID-
19 vaccines among health care workers in South Africa.
Duration: July 2022 to October 2022
Screened = 334 and Enrolled = 322
Principle Investigator: Prof Shaun Barnabas
Funder: MRC
(vi) CoVPN 3003
VAC31518COV3001; Phase 3 – ENSEMBLE A Randomized, Double-blind, Placebo- controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
Duration: 2020 to Feb 2023
Screened = 202 and Enrolled = 129
Principle Investigator: Dr Shaun Barnabas
Funder: UCLA / NIH / Jansens
(vii) CoVPN 3008
Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern
Duration: November 2020 to May 2024
Screened = 397 and Enrolled = 272
Principle Investigator: Dr Samantha Fry
Funder: UCLA / NIH
?2) Treatment
(i) Together
An Adaptive Randomized Platform Trial to Investigate the Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults
Duration: August 2020 to October 2020
Screened = 29 and Enrolled = 27
Principle Investigator: Prof Eric DeCloedt
Funder: Washington 肆客足球 / Gates Foundation
?
C TB
? (i) A5349 / S31
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial.
Duration: Nov 2016 to July 2021
Screened = 45 and Enrolled = 36
Principle Investigator: Dr Stefanus Malherbe
Funder: TBTC / ACTG / BMRI
D Infectious diseases
(i) A5360
A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations who are HCV Treatment Na?ve with Evidence of Active HCV Infection: The MINMON Study
Duration: July 2018 to February 2021
Screened = 5 & Enrolled 4
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
E Other
(i) A5243
Plan for Obtaining Human Biological Samples at Non-US Clinical Research Sites for Currently Unspecified Genetic Analyses Version 2.0 - 13 March 2013
Duration: Sept 2017 to January 2021
Screened = 100 & Enrolled 100
Principle Investigator: Dr Marije van Schalkwyk Funder: ACTG
(ii) A5302
BioBank for Surrogate Marker Research for TB (B-SMART) IMPAACT 2008: Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 with Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants, Version 2.0, dated 29 May 2017.
Duration: December 2018 to June 2021
Screened = 6 and Enrolled = 6
Principle Investigator: Dr Stefanus Malherbe
Funder: ACTG
(iii) A5375
An Open-Label, Phase II Pharmacokinetic Study to Evaluate Double-Dose
Levonorgestrel Emergency Contraception in Combination with Efavirenz-Based
Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
Duration: November 2019 to December 2020
Screened = 13 & Enrolled 8
Principle Investigator: Dr Marije van Schalkwyk
Funder: ACTG
V NEONATAL
A HIV
1) Therapeutic
(i) ABC Neo Nate
Pharmacokinetics and safety of abacavir in HIV-exposed and HIV-infected infants less than 3 months of chronological age
Duration: November 2019 to February 2020
Screened = 10 and Enrolled = 10
Principle Investigator: Prof Adri Bekker
Funder: UNITAID
(ii) Petite
Open label, single arm, two-stage trial to evaluate the single and multi-dose pharmacokinetics and safety of the abacavir/lamivudine/lopinavir/ritonavir (30/15/40/10mg) (4-in-1) fixed-dose granule formulation in HIV-exposed neonates.
Duration: May 2020 to August 2022
Screened = 51 and Enrolled = 46
Principle Investigator: Prof Adri Bekker
Funder: UNITAID
2) Prophylaxis
(i) P1043
Phase II randomized trial of the safety and efficacy of three neonatal regimes for prevention of intrapartum HIV-1 transmission.
Duration: January 2007 to December 2010
Screened = 925 and Enrolled = 153
Principle Investigator: Prof Gerhard Theron
Funder: IMPAACT.
B TB
(i) VPM – Pilot study
Phase II Open Label, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison with BCG in HIV-unexposed, BCG naive newborn infants in South Africa
Duration: January 2011 to November 2013
Screened = 126 and Enrolled = 48
Principle Investigator: Prof Mark Cotton
Funder: Vakzine Project Germany
(ii) VPM – 2014
Phase II an Open Label, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison with BCG in HIV-unexposed, BCG naive Newborns in South Africa.
Duration: August 2014 to November 2017
Screened = 166 and Enrolled = 112
Principle Investigator: Prof Mark Cotton
Funder: Serum Institute of India
