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Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH

NCT04944654 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-05-13

No results posted yet for this study

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).

Conditions

  • Human Immunodeficiency Virus

Interventions

DRUG

BIKTARVY 50Mg-200Mg-25Mg Tablet

Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Imperial College London

    collaborator OTHER

  • Chelsea and Westminster NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Marta Boffito · Chelsea and Westminster Hospital NHS Foundation Trust, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2023-05-11
Completion
2023-05-11

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944654 on ClinicalTrials.gov