Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337032
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-22
Brief Title:
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to provide continued access to the study drugs 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 bictegraviremtricitabinetenofovir BFTAF for participants who completed a Gilead parent study evaluating drugs for HIV treatment
To evaluate the safety of the study drugs in participants with HIV-1
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 bictegraviremtricitabinetenofovir BFTAF for participants who completed a Gilead parent study evaluating drugs for HIV treatment
To evaluate the safety of the study drugs in participants with HIV-1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None