Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
Recruiting · NCT06485154 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Witwatersrand, South Africa
View the official record on ClinicalTrials.gov →Interventions studied
TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
What this trial is about
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.
Who can take part
Age range
15 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
3 locations listed.
- Ezintsha, a division of Wits Health Consortium - Johannesburg, Gauteng, South Africa
- Africa Health Research Institute (AHRI) - Durban, KwaZulu-Natal, South Africa
- Desmond Tutu Health Foundation - Cape Town, Western Cape, South Africa