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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06337032
Other study ID # GS-US-380-6684
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 2024
Est. completion date March 2034

Study information

Verified date May 2024
Source Gilead Sciences
Contact Gilead Clinical Study Information Center
Phone 1-833-445-3230 (GILEAD-0)
Email GileadClinicalTrials@gilead.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date March 2034
Est. primary completion date March 2034
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
F/TAF (High Dose Tablet)
200/25 mg fixed-dose combination (FDC) tablet administered orally
F/TAF (Low Dose Tablet)
200/10 mg FDC tablet administered orally
F/TAF (Lowest Dose Tablet)
120/15 mg FDC tablet administered orally
F/TAF (High Dose TOS)
60/7.5 mg tablet for oral suspension (TOS) administered orally
F/TAF (Low Dose TOS)
30/3.75 mg TOS administered orally
F/TAF (Lowest Dose TOS)
15/1.88 mg TOS administered orally
E/C/F/TAF
150/150/200/10 mg tablet administered orally
E/C/F/TAF (Low Dose)
90/90/120/6 mg tablet administered orally
Cobicistat (High Dose)
150 mg tablet administered orally
Cobicistat (Low Dose)
90 mg tablet administered orally
Cobicistat (TOS)
30 mg TOS administered orally
B/F/TAF (High Dose)
50/200/25 mg FDC tablet administered orally
B/F/TAF (Low Dose)
30/120/15 mg FDC tablet administered orally
B/F/TAF (High Dose TOS)
15/60/7.52 mg TOS administered orally
B/F/TAF (Low Dose TOS)
7.5/30/3.76 mg TOS administered orally
B/F/TAF (Lowest Dose TOS)
3.76/15/1.88 mg TOS administered orally
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
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)
ATV
Administered according to the prescribing information
DRV
Administered according to the prescribing information
Lopinavir Boosted with ritonavir (LPV/r)
Administered according to the prescribing information

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study Up to 9.5 Years
Secondary Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Up to 9.5 Years
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