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

Phase 4RecruitingNCT06337032

Gilead Sciences350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

350

Conditions

HIV-1-infection

Interventions

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

F/TAF (Low Dose Tablet)DRUG

200/10 mg FDC tablet administered orally

F/TAF (Lowest Dose Tablet)DRUG

120/15 mg FDC tablet administered orally

F/TAF (High Dose TOS)DRUG

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

F/TAF (Low Dose TOS)DRUG

30/3.75 mg TOS administered orally

F/TAF (Lowest Dose TOS)DRUG

15/1.88 mg TOS administered orally

E/C/F/TAFDRUG

150/150/200/10 mg tablet administered orally

E/C/F/TAF (Low Dose)DRUG

90/90/120/6 mg tablet administered orally

Cobicistat (High Dose)DRUG

150 mg tablet administered orally

Cobicistat (Low Dose)DRUG

90 mg tablet administered orally

Cobicistat (TOS)DRUG

30 mg TOS administered orally

B/F/TAF (High Dose)DRUG

50/200/25 mg FDC tablet administered orally

B/F/TAF (Low Dose)DRUG

30/120/15 mg FDC tablet administered orally

B/F/TAF (High Dose TOS)DRUG

15/60/7.52 mg TOS administered orally

B/F/TAF (Low Dose TOS)DRUG

7.5/30/3.76 mg TOS administered orally

B/F/TAF (Lowest Dose TOS)DRUG

3.76/15/1.88 mg TOS administered orally

3rd ARV AgentDRUG

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

Nucleos(t)ide reverse transcriptase inhibitors (NRTI)DRUG

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)

ATVDRUG

Administered according to the prescribing information

DRVDRUG

Administered according to the prescribing information

Lopinavir Boosted with ritonavir (LPV/r)DRUG

Administered according to the prescribing information

Eligibility

Sex: ALLMin age: 1 Month

Medical Language ↔ Plain English

Key Inclusion Criteria: * Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation. Key Exclusion Criteria: * Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit. * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). * Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch. * For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance. * For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients. * Ongoing treatment with or prior use of any prohibited medications. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (14)

Helios Salud

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Hospital del Niño

Panama City, Panama

ACTIVE_NOT_RECRUITING

University of Stellenbosch

Cape Town, South Africa

RECRUITING

Enhancing Care Foundation

Durban, South Africa

RECRUITING

WITS RHI Research Centre

Johannesburg, South Africa

RECRUITING

Rahima Moosa Mother and Child Hospital

Johannesburg, South Africa

RECRUITING

Be Part Yoluntu Centre

Paarl, South Africa

RECRUITING

The Aurun Institute

Pretoria, South Africa

RECRUITING

Perinatal HIV Research Unit

Soweto, South Africa

RECRUITING

Faculty of Medicine - Mahidol University

Bangkok Noi, Thailand

ACTIVE_NOT_RECRUITING

...and 4 more locations

Outcomes

Primary Outcomes

Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study

Time frame: Up to 9.5 Years

Secondary Outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to 9.5 Years

Central Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Data from ClinicalTrials.gov

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