Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial

Recruiting now · Phase 4

Conditions studied: HIV Prevention

In brief

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.

Key facts

Study ID

NCT06485154

Run by

University of Witwatersrand, South Africa

People needed

100

Starts

2024-06-01

Expected to finish

2026-08-31

Last updated by the study team

2026-06-09

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female.
• Age ≥ 15 years, inclusive, at the time of signing the informed consent.
• Body weight ≥ 35 kg.
• Confirmed HIV-1 infection.
• Exposure to at least one dose of CAB-LA PrEP in the past 12 months.
• Consent to initiation of ART.
• Estimated glomerular filtration rate (eGFR) > 50 min/mL

You may not qualify if…

• 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.
• Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:
• tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;
• anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
• herbal products (e.g., St John's Wort).
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.
• Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. This including inability or an unwillingness to be followed up for the study period.

Where it is running

• Ezintsha, a division of Wits Health Consortium — Johannesburg, Gauteng, South Africa (enrolling)
• Africa Health Research Institute (AHRI) — Durban, KwaZulu-Natal, South Africa (enrolling)
• Desmond Tutu Health Foundation — Cape Town, Western Cape, South Africa (enrolling)

Full record on ClinicalTrials.gov

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