Clinical trial
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
Name
EZ-BB-036
Description
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.
Trial arms
Trial start
2024-06-01
Estimated PCD
2026-06-30
Trial end
2026-08-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, a combination of dolutegravir (integrase strand transfer inhibitor \[INSTI\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside reverse transcriptase inhibitors), is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg
Arms:
TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
Other names:
Acriptega
Size
100
Primary endpoint
To evaluate the efficacy of TLD as first-line antiretroviral therapy (ART) in participants with HIV-1 infection and CAB-LA PrEP exposure in the past 12 months
At 6 Months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Oral - 1 tablet (300/300/50 mg TDF/3TC/DTG) daily', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Age ≥ 15 years, inclusive, at the time of signing the informed consent.'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-07-03
1 organization
1 product
1 indication
Organization
University of WitwatersrandIndication
HIV