Study Details

PROTOCOL 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.

Participation Requirements

Age

1 Month +

Sex

ALL

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

August 2024 - March 2034

Study Type

INTERVENTIONAL

Study Phase

PHASE4

Product

F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet), F/TAF (High Dose TOS), F/TAF (Low Dose TOS), F/TAF (Lowest Dose TOS), E/C/F/TAF, E/C/F/TAF (Low Dose), Cobicistat (High Dose), Cobicistat (Low Dose), Cobicistat (TOS), B/F/TAF (High Dose), B/F/TAF (Low Dose), B/F/TAF (High Dose TOS), B/F/TAF (Low Dose TOS), B/F/TAF (Lowest Dose TOS), 3rd ARV Agent, Nucleos(t)ide reverse transcriptase inhibitors (NRTI), ATV, DRV, Lopinavir Boosted with ritonavir (LPV/r)

Eligibility Information

Inclusion Criteria

Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.

Exclusion Criteria

Individuals planning to switch to B/F/TAF on Day 1 cannot have 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 must not have 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

Locations (11)

Helios Salud

Buenos Aires, Argentina, C1141 ACG

Hospital del Niño

Panama City, Panama, 0816-00383

University of Stellenbosch

Cape Town, South Africa, 7505

Enhancing Care Foundation

Durban, South Africa, 3629

Rahima Moosa Mother and Child Hospital

Johannesburg, South Africa, 2112

Be Part Yoluntu Centre

Paarl, South Africa, 7626

The Aurun Institute

Pretoria, South Africa, 0087

Perinatal HIV Research Unit

Soweto, South Africa, 2013

Faculty of Medicine - Mahidol University

Bangkok Noi, Thailand, 10700

Khon Kaen University

Khon Kaen, Thailand, 40002

Joint Clinical Research Centre

Kampala, Uganda, 10005

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

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