NCT02016924 - Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV | Biotech Hunter

Enrollment

133

Participants

Timeline

Start Date

January 16, 2014

Primary Completion Date

June 13, 2025

Study Completion Date

March 31, 2027

Conditions

Acquired Immune Deficiency Syndrome (AIDS)HIV Infections

Interventions

DRUG

ATV

Capsules administered once daily according to dosing recommendations per product monograph

DRUG

DRV

Tablets administered once daily according to dosing recommendations per product monograph

DRUG

Cobicistat

Tablets administered orally once daily with food

DRUG

Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC).

DRUG

F/TAF

Tablets administered orally once daily

DRUG

LPV/r

Solution administered orally

DRUG

Third Unboosted Drug

ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.

DRUG

Cobicistat TOS

Tablets for oral suspension

DRUG

F/TAF TOS

Tablets for oral suspension

Trial Locations (23)

87

The Aurum Institute: Pretoria Clinical Research Centre, Pretoria

256

MU-JHU Research Collaboration/MU-JHU Care Ltd, Kampala

1151

Hospital General de Agudos Cosme Argerich, Buenos Aires

2013

Perinatal HIV Research Unit, Soweto

2093

Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd, Johannesburg

3629

King Edward VIII Hospital, Durban

7505

University of Stellenbosch, Cape Town

9300

University of the Free State, Bloemfontein

10330

HIV-NAT, Bangkok

10700

Siriraj Hospital, Bangkok

20010

The George Washington University, Washington D.C.

33606

University of South Florida, Tampa

38105

St. Jude Children's Research Hospital, Memphis

40002

Srinagarind Hospital, Khon Kaen

77030

University of Texas Health Science Center of Houston, Houston

80045

University of Colorado Denver, Aurora

90095

Peter Morton Medical Building, Los Angeles

90806

Pediatric Infectious Disease Associates, Long Beach

C1141 ACG

Helios Salud, Buenos Aires

Unknown

SICRA-TASO Mulago National Referral Hospital, Kampala

AMBSO Masaka Clinical Research Site, Masaka

University of Zimbabwe Clinical Research Centre, Harare

W2 1NY

Imperial College Healthcare NHS Trust, London