Clinical trial NCT06337032: A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Official title: An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-03-29
Enrollment: 350
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study
timeFrame: Up to 9.5 Years
Secondary outcomes:
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 9.5 Years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Helios Salud
city: Panama City
country: Panama
facility: Hospital del Niño
city: Cape Town
country: South Africa
facility: University of Stellenbosch
city: Durban
country: South Africa
facility: Enhancing Care Foundation
city: Johannesburg
country: South Africa
facility: Rahima Moosa Mother and Child Hospital
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre
city: Pretoria
country: South Africa
facility: The Aurun Institute
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine - Mahidol University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre
city: Harare
country: Zimbabwe
facility: University of Zimbabwe Clinical Research Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: