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Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH - Trial NCT04944654

Access comprehensive clinical trial information for NCT04944654 through Pure Global AI's free database. This Phase 4 trial is sponsored by Chelsea and Westminster NHS Foundation Trust and is currently Not yet recruiting. The study focuses on Human Immunodeficiency Virus. Target enrollment is 50 participants.

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NCT04944654
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04944654
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Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH
Efficacy, Tolerability and Acceptability of the Single Table Regimen (STR) Biktarvyยฎ by Trans People Living With HIV (TPLWH)

Study Focus

BIKTARVY 50Mg-200Mg-25Mg Tablet

Interventional

drug

Sponsor & Location

Chelsea and Westminster NHS Foundation Trust

Timeline & Enrollment

Phase 4

Feb 01, 2022

Oct 01, 2023

50 participants

Primary Outcome

Measure of viral load

Summary

This is a clinical trial for TPLWH (Trans People Living with HIV) who are stable on cART with
 an undetectable viral load or a detectable viral load but no resistance to NRTIs and InSTI.
 Following written consent and screening procedures, study subjects will undergo a switch (or
 will restart) of their combination antiretroviral therapy (cART) to Biktarvy. The goal of
 this research project is to recruit an understudied population into a controlled clinical
 trial aimed at optimizing TPLWH cART. This will be demonstrated by measuring viral load
 outcomes at regular intervals, with a focus on viral load results 48 weeks after Biktarvy
 initiation (primary outcome).

ICD-10 Classifications

Human immunodeficiency virus [HIV] disease
Unspecified human immunodeficiency virus [HIV] disease
Human immunodeficiency virus [HIV] disease resulting in other conditions
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Asymptomatic human immunodeficiency virus [HIV] infection status

Data Source

ClinicalTrials.gov

NCT04944654

Non-Device Trial