Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
ConditionHIV Prevention
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity of Witwatersrand, South Africa
About this trial
This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.
Eligibility criteria
Qualifiers
Male or female.
Age ≥ 15 years, inclusive, at the time of signing the informed consent.
Body weight ≥ 35 kg.
Confirmed HIV-1 infection.
Disqualifiers
Any previous exposure to DTG.
Concurrent or recent (within the preceding 3 months) participation in another interventional clinical trial with a compound likely to interfere with any of the investigational medicinal products.
Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.
tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;
Trial design
Treatments tested in this trial
- TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Witwatersrand, South Africa
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov