A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa

Recruiting now · Not applicable

Conditions studied: HIV Infections, AIDS, Virologic Failure

In brief

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.

Key facts

Study ID

NCT05373758

Run by

Massachusetts General Hospital

People needed

648

Starts

2024-02-07

Expected to finish

2027-06-30

Last updated by the study team

2026-03-19

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• RK Khan Hospital Clinic — Durban, South Africa (enrolling)
• Mbarara City Clinic — Mbarara, Uganda (enrolling)
• Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic — Mbarara, Uganda (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.