中国体育彩票

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FAMCRU
Welcome to Stellenbosch 中国体育彩票

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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