Switching to Dolutegravir bases regimens vs Rilpivirine based regimens in antiretroviral experienced patients with virological supression: randomized controlled trial, open label
Phase 4
Recruiting
- Conditions
- Patients more than 18 years of age who have previously received antiretroviral regimens Tenofovir/Emtricitabine/Efavirenz for more than or equal to 6 months and have an HIV-1 RNA viral load of less than 20 copies/ml within 6 months before the study.HIV, Tenofovir/ Emtricitabine/Dolutegravir, Tenofovir/ Emtricitabine/ Rilpivirine, weight gain, metabolic syndrome
- Registration Number
- TCTR20211229003
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
Patients more than 18 years of age who have previously received antiretroviral regimens Tenofovir/Emtricitabine/Efavirenz for more than or equal to 6 months and have an HIV-1 RNA viral load of less than 20 copies/ml within 6 months before the study.
Exclusion Criteria
1. Infected with HIV 2 RNA, 2. Evidence that one of the antiretroviral drug resistance genes is found, 3. Drug interactions such as proton pump inhibitors, H2 receptor antagonists, rifampicin, and anticonvulsants, 4. Being pregnant or breastfeeding, 5. The renal function calculated from the Cockcroft Gault equation is less than 60 mL/min, 6. Have a psychiatric illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Virological suppression at 6 months after end of the intervention HIV viral load
- Secondary Outcome Measures
Name Time Method the changes in blood lipids, blood sugar, body weight, subcutaneous fat mass, and the waist circumference at 6 months after end of the intervention Laboratory test