NCT06485154 Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
| NCT ID | NCT06485154 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Witwatersrand, South Africa |
| Condition | HIV Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
FRANCOIS WD VENTER, PhD
STUDY DIRECTOR
Ezintsha, a division of Wits Health Consortium
Frequently Asked Questions
Who can join the NCT06485154 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying HIV Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06485154 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06485154 currently recruiting?
Yes, NCT06485154 is actively recruiting participants. Contact the research team at bdyariwe@ezintsha.org for enrollment information.
Where is the NCT06485154 trial being conducted?
This trial is being conducted at Johannesburg, South Africa, Durban, South Africa, Cape Town, South Africa.
Who is sponsoring the NCT06485154 clinical trial?
NCT06485154 is sponsored by University of Witwatersrand, South Africa. The principal investigator is FRANCOIS WD VENTER, PhD at Ezintsha, a division of Wits Health Consortium. The trial plans to enroll 100 participants.
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