NCT05373758Recruiting
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to \<50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 648 (estimated)
- First submitted
- 6 May 2022
- Start date
- 7 Feb 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT05373758
What you commit to
- Study type: Interventional
- Planned participants: 648
- From 7 Feb 2024 to the primary completion date, 30 Jun 2027
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
Other
- Plans to transfer out of the clinic within the next 48 weeks
- Plans to move out of the study catchment area within the next 48 weeks
Who the study is looking for
- Age 15 years and above
- Enrolled in HIV care at one of the study clinics
- History of two HIV-1 RNA viral load measurements \>1,000 copies/mL while on TLD
- On TLD for at least 12 months
- Lives within 100 kilometers of study clinic
- Pregnant women are eligible for enrollment.
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic Coordinator of this site? Confirm its status | Mbarara | Uganda | Recruiting |
| Mbarara City Clinic Coordinator of this site? Confirm its status | Mbarara | Uganda | Recruiting |
| RK Khan Hospital Clinic Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.