A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

PHASE4RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

August 27, 2024

Primary Completion Date

March 31, 2034

Study Completion Date

March 31, 2034

Conditions
HIV-1-infection
Interventions
DRUG

F/TAF (High Dose Tablet)

200/25 mg fixed-dose combination (FDC) tablet administered orally

DRUG

F/TAF (Low Dose Tablet)

200/10 mg FDC tablet administered orally

DRUG

F/TAF (Lowest Dose Tablet)

120/15 mg FDC tablet administered orally

DRUG

F/TAF (High Dose TOS)

60/7.5 mg tablet for oral suspension (TOS) administered orally

DRUG

F/TAF (Low Dose TOS)

30/3.75 mg TOS administered orally

DRUG

F/TAF (Lowest Dose TOS)

15/1.88 mg TOS administered orally

DRUG

E/C/F/TAF

150/150/200/10 mg tablet administered orally

DRUG

E/C/F/TAF (Low Dose)

90/90/120/6 mg tablet administered orally

DRUG

Cobicistat (High Dose)

150 mg tablet administered orally

DRUG

Cobicistat (Low Dose)

90 mg tablet administered orally

DRUG

Cobicistat (TOS)

30 mg TOS administered orally

DRUG

B/F/TAF (High Dose)

50/200/25 mg FDC tablet administered orally

DRUG

B/F/TAF (Low Dose)

30/120/15 mg FDC tablet administered orally

DRUG

B/F/TAF (High Dose TOS)

15/60/7.52 mg TOS administered orally

DRUG

B/F/TAF (Low Dose TOS)

7.5/30/3.76 mg TOS administered orally

DRUG

B/F/TAF (Lowest Dose TOS)

3.76/15/1.88 mg TOS administered orally

DRUG

3rd ARV Agent

A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country

DRUG

Nucleos(t)ide reverse transcriptase inhibitors (NRTI)

NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)

DRUG

ATV

Administered according to the prescribing information

DRUG

DRV

Administered according to the prescribing information

DRUG

Lopinavir Boosted with ritonavir (LPV/r)

Administered according to the prescribing information

Trial Locations (12)

2013

RECRUITING

Perinatal HIV Research Unit, Soweto

2112

RECRUITING

Rahima Moosa Mother and Child Hospital, Johannesburg

3629

RECRUITING

Enhancing Care Foundation, Durban

7505

RECRUITING

University of Stellenbosch, Cape Town

7626

RECRUITING

Be Part Yoluntu Centre, Paarl

10005

RECRUITING

Joint Clinical Research Centre, Kampala

10700

RECRUITING

Faculty of Medicine - Mahidol University, Bangkok Noi

40002

RECRUITING

Khon Kaen University, Khon Kaen

C1141 ACG

RECRUITING

Helios Salud, Buenos Aires

0816-00383

RECRUITING

Hospital del Niño, Panama City

0087

RECRUITING

The Aurun Institute, Pretoria

Unknown

RECRUITING

University of Zimbabwe Clinical Research Centre, Harare

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT06337032 - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments | Biotech Hunter | Biotech Hunter