Medicines Control Authority of Zimbabwe

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CT278/2024

GS-US-380-6684
21-12-2023

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: GS-US-380-6684

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

Primary Sponsor Details
Gilead Sciences Inc

Secondary Sponsor Details
Hilda Angela Mujuru
Principal Investigator
hmujuru@mweb.co.zw
+263 772259666
No. 2 Allan Wilson Belgravia, Harare
University of Zimbabwe Clinical Research Center
Hilda Angela Mujuru
Principal Investigator
hmujuru@mweb.co.zw
+263772259666
No 2 Allan Wilson Belgravia, Harare
University of Zimbabwe

Argentina, Panama, South Africa, Thailand, Uganda and Zimbabwe
Gilead Sciences
HIV
B/F/TAF (Biktarvy®), F/TAF (Descovy®), E/C/F/TAF (Genvoya®), Cobicistat (Tybost®)..
As stated in table below

  Inclusion Criteria:

  Participants who meet all of the following inclusion criteria are eligible for participation in this study:

  • 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.
  • Parent or legal guardian or participant ≥ 18 years of age and able to provide written informed consent. Participants < 18 years of age will provide written assent if they are able per investigator assessment, and if applicable, per their local institutional guidelines and local country regulations.

  Exclusion Criteria

  Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study:

  • Participants 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: participants 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).

•        Participants 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.

Primary Endpoint:

Number of eligible participants who have received access to the study drug(s) in the study
9.0 DESIGN OF THE TRIAL
Opened

If controlled
No
No
No
No
No
Yes
Single arm study
No
No
No
Yes
70
All participants who are on parent study medication and have completed a designated Gilead parent study evaluating drugs for HIV treatment per country are eligible to enroll in this study.
350
UP TO 10 YEARS