Status:
ACTIVE_NOT_RECRUITING
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
Lead Sponsor:
University of Witwatersrand, South Africa
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
HIV Prevention
Eligibility:
All Genders
15+ years
Phase:
PHASE4
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 Antir...
Detailed Description
Study participants are HIV-1 infected adult patients recruited. A target of 100 participants will be enrolled and started on Tenofovir, Lamivudine, and Dolutegravir at enrolment. Clinical assessments ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06485154
Start Date
June 1 2024
End Date
August 31 2026
Last Update
July 3 2024
Active Locations (3)
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1
Ezintsha, a division of Wits Health Consortium
Johannesburg, Gauteng, South Africa, 2193
2
Africa Health Research Institute (AHRI)
Durban, KwaZulu-Natal, South Africa, 3935
3
Desmond Tutu Health Foundation
Cape Town, Western Cape, South Africa, 7925