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Clinical trial Recruiting at 3 sites Phase 4 Interventional Ages 15 and up

Post-Injectable Cabotegravir PrEP to ART Transition: See if a TLD regimen works for people starting HIV treatment after prior Cabotegravir-Long-acting PrEP

Official title: Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial

Run by University of Witwatersrand, South Africa · NCT06485154 · Data updated 2026-11-12

This study tests if a standard TLD regimen can effectively control HIV in people who recently used Cabotegravir-Long-acting PrEP and are starting first-line ART.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages15 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Witwatersrand, South Africa
Academic / other
Locations3 sites (Johannesburg, Gauteng and 2 other locations)
StatusRecruiting
StartedJune 1, 2024
Main results expectedJune 30, 2026
Study endsAugust 31, 2026
Registry record updatedJune 9, 2026
Trial IDNCT06485154 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults and adolescents aged 15 years and older with confirmed HIV-1 infection who have had at least one CAB-LA PrEP exposure in the past 12 months and are willing to initiate ART.

Probably not a fit

Individuals without prior Cabotegravir exposure or those unable to tolerate or adhere to the TLD regimen may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, single-arm, open-label study enrolling up to 100 adults with newly diagnosed HIV-1 infection who have had prior Cabotegravir-Long-acting PrEP exposure in the previous year. Participants begin Tenofovir, Lamivudine, and Dolutegravir (TLD) as first-line ART and are followed for 12 months with scheduled visits to monitor virologic response and safety. The study also aims to assess feasibility of recruiting and testing baseline resistance patterns when prior Cabotegravir exposure is present, to inform programmatic rollout in settings where pretreatment genotyping may be limited. This two-phase design seeks to identify safe and effective regimens for individuals with prior Cabotegravir exposure after HIV diagnosis, with Phase I focusing on proof of concept and resistance considerations.

Why it matters

Potential benefit: If successful, participants may achieve virologic suppression with a standard, accessible ART regimen after prior Cabotegravir exposure, contributing to improved treatment options.

How similar studies have gone: Previous work in similar contexts has explored ART regimens post-PrEP exposure, but this study provides a novel, targeted approach with a genotypic resistance component in the Cabotegravir-exposed population.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

1. Any previous exposure to DTG.
2. 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.
3. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.
4. 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:

   1. tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;
   2. anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
   3. herbal products (e.g., St John's Wort).
5. 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.
6. 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's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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HIV Prevention 282University of Witwatersrand, South Africa 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.