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

Summary

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.

The primary objectives of this study are as follows:

* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1.

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

Sponsors & Collaborators

• Gilead Sciences

  lead INDUSTRY

Principal Investigators

• Gilead Study Director · Gilead Sciences

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-27

Primary Completion

2034-03-31

Completion

2034-03-31

FDA Drug

Yes

Countries

• Argentina
• Panama
• South Africa
• Thailand
• Uganda
• Zimbabwe

Study Locations