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Switching to Dolutegravir bases regimens vs Rilpivirine based regimens in antiretroviral experienced patients with virological supression: randomized controlled trial, open label

Switching to Dolutegravir bases regimens vs Rilpivirine based regimens in antiretroviral experienced patients with virological supression: randomized controlled trial, open label

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211229003
Enrollment
210
Registered
2021-12-29
Start date
2021-10-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Tenofovir/ Emtricitabine/Dolutegravir is an oral medication.,Tenofovir/ Emtricitabine/ Rilpivirine is an oral medicaton.
Active Comparator Drug,Active Comparator Drug
Tenofovir/ Emtricitabine/Dolutegravir,Tenofovir/ Emtricitabine/ Rilpivirine

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Virological suppression at 6 months after end of the intervention HIV viral load

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactRattagan Kajeekul

Ministry of Health

rattagankajekul@gmail.com0619451942

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Sep 17, 2026