FAMCRU Current Research
?
I Matern??al
A HIV
1) Therapeutic
2) Prophylaxis
3) Cure
4) PMTCT
5) Other
B TB
1) Therapeutic
2) Prophylaxis
(i) Dolphin
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: Nov 2023
Screened = 13 and Enrolled = 7
Principle Investigator: Dr Marije van Schalkwyk
Funder: Aurum / UNITAID
C Infectious diseases
1) RSV
(i) Pfizer Matisse
A Phase 3, randomized, double-blinded, placebo controlled trial to evaluate the efficiancy and safety of a respiratory Syncytial virus (RSV) prefision F Subunit vaccine in infants born to woman vaccinated during pregnancy.
Duration: March 2021 -current
Screened = 311 and Enrolled = 221
Principle Investigator: Prof Shaun Barnabas
Funder: Pfizer
2) Meningococcal
3) Group B Streptococcus
(i) GBS 1009 – Worcester
A Phase 3, Randomized, Observer-Blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of a Multivalent Group B Streptococcus Vaccine In Healthy Pregnant Women And Their Infants
Duration: still to start
Screened = 0 and Enrolled = 0
Principle Investigator: Prof Shaun Barnabas
Funder: Pfizer
D Other
(i) IMPAACT 2026
Pharmacokinetic Properties of Antiretroviral and Anti Tuberculosis Drugs during
Pregnancy and Postpartum
Duration: May 2023 – current
Screened = 7 Moms and Enrolled = 6 Moms and babies
Principle Investigator: Dr Marije van Schalkwyk
Funder: IMPAACT
II Paediatric?
A HIV
1) Therapeutic
(i) Gilead 380 1474
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral
Activity of the GS9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF)
Fixed Dose Combination (FDC) in HIV-1 Infected Virologically Suppressed
Adolescents and Children"
Duration: Jan 2016
Screened = 8 and Enrolled = 8
Principle Investigator: Dr Yasmeen Alkhawaya
Funder: Gilead
(ii) Gilead 216 – 0128
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating
Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir
(ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir
Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric
Participants
Duration: Nov 2020
Screened = 2 and Enrolled = 2
Principle Investigator: Prof Shaun Barnabas
Funder: Gilead
(iii) GSK 205858
Open-label access to dolutegravir for HIV-1 infected children and adolescents
completing IMPAACT Study PI093 and P2019
Duration: March 2019 - current
Screened = 8 and Enrolled = 8
Principle Investigator: Prof Mark Cotton
Funder: GSK
(iv) MSD MK 1439 066
A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine in Participants With HIV-1 Aged 4 Weeks to <12 Years of Age and Weighing <35 kg
Duration: August 2023 -
Screened = 8 and Enrolled = 7
Principle Investigator: Prof Shaun Barnabas
Funder: MSD
(v) SHIELD (PENTA 22)
A multicentre, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance.
Duration: August 2023 - current
Screened 1 and Enrolled 1
Principle Investigator: Dr Lisa Frigati
Funder: Penta Foundation
2) Prophylaxis
3) Cure
(i) P1115
Very early intensive treatment of HIV- infected infants to achieve HIV remission: A Phase I/II proof of concept study.
Duration: Nov 2015
Screened = 13 and Enrolled = 13
Principle Investigator: Prof Mark Cotton
Funder: IMPAACT
B HIV / TB Epidemiology / Observation
(i) Celebrate
Acceptability, feasibility, and usability of broadly neutralizing antibody
injections to prevent vertical transmission of HIV: A qualitative study amongst
mothers, community and family members, health care providers, and
stakeholders. tablet in HIV-exposed neonates.
Duration January 2024
Screened =and Enrolled
Principle Investigator: Dr Sharon Kruger
Funder: IAVI
(ii) Earth
A prospective, observational, cohort, multicentre study of Early Anti-Retroviral
Treatment in HIV- infected Infants.
Duration: Aug 2018
Screened = 50 and Enrolled =5 0
Principle Investigator: Prof Mark Cotton
Funder: EDCTP
(iii) IMPAACT 2028
Long-Term Clinical, Immunologic, and Virologic Profiles of Children who Received Early Treatment for HIV
Duration: February 2023 - current
Screened 37 and Enrolled = 36
Principle Investigator: Prof Shaun Barnabas
Funder: IMPAACT
?C TB
1) Therapeutic
(i) VPM -Prime
A multicenter, phase III, double-blind, randomized, active-controlled study to
evaluate the efficacy and safety of VPM1002 in comparison to BCG in
prevention of Mycobacterium tuberculosis infection in newborn infants
Duration: December 2020 –
Screened = 184 and Enrolled = 159
Principle Investigator: Prof Shaun Barnabas
Funder: Serum Institute of India
2) Prophylaxis
(i) MTBVAC 203
MTBVAC in Newborns: Randomised, Double-blind Controlled Phase 3 Trial to evaluate the Efficacy, Safety and Immunogenicity of MTBVAC administered in healthy HIV unexposed and HIV exposed uninfected newborns in Tuberculosis-Endemic Regions of Sub-Saharan Africa.
Duration: Feb 2023 -
Screened = 0 and Enrolled = 208
Principle Investigator: Prof Helena Rabie
Funder: Biofabri / NIH
(ii) IMPAACT 2035
Phase I/II Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination against Tuberculosis in Pre- Adolescents Living with and without HIV in South Africa
Duration: still to start
Screened = and Enrolled =
Principle Investigator: Dr Sam du Toit
Funder: IMPAACT
D Infectious diseases
1) Respiratory Syncytial Virus – RSV
(i) MSD MK 1654 004
A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
Duration:January 2021 -
Screened = 69 and Enrolled = 65
Principle Investigator: Prof Shaun Barnabas
Funder: MSD
(ii) MSD MK 1654 007
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Duration: April 2022 -
Screened = 17 and Enrolled = 15
Principle Investigator: Prof Shaun Barnabas
Funder: MSD
2) Pneumococcus
3) Rotavirus
4) Meningcoccus
(i) GSK MEN
A Phase II, randomized, partially blinded study to assess the safety, tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administered to healthy infants. Amendment 1, 1 Sep 2021
Duration: September 2023 -
Screened = 40 and Enrolled = 39
Principle Investigator: Prof Shaun Barnabas
Funder: GSK
(ii) MEQ00064
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal
Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (MEQ00064)
Duration: still to start
Screened = 0 and Enrolled = 0
Principle Investigator: Prof Shaun Barnabas
Funder: Sanofi Pasteur
E Neurodevelopment
F Other
HEU
III Adolescent
A HIV
1) Therapeutic
(i) GSK Dance ViiV 205861
An open-label, single arm study to evaluate the week 48 efficacy and safety of a two drug regimen of dolutegravir/lamivudine (DTG/3TC) as a fixed dose combination (FDC), in antiretroviral therapy (ART)-naive HIV-1-infected adolescents, ≥12 to <18 years of age who weigh at least 40 kg"
Duration: February 2019 - current
Screened = 5 and Enrolled = 1
Principle Investigator: Prof Shaun Barnabas
Funder: GSK
(ii) IMPAACT 2017
Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics
of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable
Rilpivirine In Virologically Suppressed HIV-Infected Children and Adolescents –
more Options for Children and Adolescents (MOCHA)
Duration: June 2022 - current
Screened = 3 and Enrolled =2
Principle Investigator: Dr Samantha Fry
Funder: IMPAACT
2) Cure
(i) Hvrricane
Targeting HIV Reservoirs in Perinatally HIV infected Children and Youth Using Prime- Boost HIVIS DNA and MVA-CMDR Vaccine regimens with or without Toll-like Receptor 4 Agonist
Duration: April 2022 to
Screened = 33 and Enrolled = 25
Principle Investigator: Prof Shaun Barnabas
?Funder: The Henry M Jackson Foundation / NIH
B Neurocogniti??ve
(i) Gold
Adolescent cognitive and brain Imaging study
Duration: Aug 2018 - current
Screened =192 and Enrolled = 192
Principle Investigator: Prof Barbara Laughton
Funder: The General Hospital Corporation d/b/a Massachusetts General Hospital
?(ii) PAVE HIV (neurocognitive)
Investigating HIV and neuroinflammation in Adolescents
Duration: March 2023 -
Screened = 40 and Enrolled = 40
Principle Investigator: Prof Mark Cotton
Funder: NIH
C Oth?er
(i) CARMA GLOBAL
Child and Adolescent Research Moving towards Alternative Interventions
Duration: June 2023-Sep 2023
Screened = 17 and Enrolled = 16
Principle Investigator: Prof Shaun Barnabas
Funder: Penta Foundation
IV Ad?ult
A H??IV?
(i) MSD MK 8591A-20
A phase III Randomized, active-controlled double blind clinical study to evaluate the Antiretroviral activity, safety, and tolerability of Doravirine / Islatravir once daily in HIV- 1 infected treatment naive participants.
Duration: June 2021 to current
Screened 15 = and Enrolled = 8
Principle Investigator: Dr Marije van Schalkwyk
Funder: MSD
(ii) MSD MK 58591A-51
A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy
Duration: July 2023 -
Screened = 6 and Enrolled = 5
Principle Investigator: Dr Marije van Schalkwyk
Funder: MSD
(iii) MSD MK 58591A-53
Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Na?ve Participants
Duration: July 2023 –
Screened = 1 and Enrolled = 1
Principle Investigator: Dr Marije van Schalkwyk
Funder: MSD
(iv) MSD MK 58591A-54
A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL
[100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Duration: July 2023
Screened = 1 and Enrolled = 1
Principle Investigator: Dr Marije van Schalkwyk
Funder: MSD
B C?OVID
1) Vaccine
2) Treatment
C TB
D Infectio?us diseases
E Oth??er
V Ne?onatal
A HIV
1) Therapeutic
(i) Petite DTG
Open label, single arm, two-stage trial to evaluate the single and multi-dose
pharmacokinetics and safety of the paediatric dolutegravir (10 mg, scored)
dispersible tablet in HIV-exposed neonates.
Duration: September 2023 to current
Screened =16 and Enrolled = 16
Principle Investigator: Prof Adrie Bekker
Funder: UNITAID
(ii) IMPAACT 2023
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir
In Neonates Exposed to HIV-1, Version 1.0, 4 October 2021
Duration: March 2023 to current
Screened = 1 and Enrolled = 1
Principle Investigator: Prof Adrie Bekker
Funder: IMPAACT?
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