NCT05373758 A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
| NCT ID | NCT05373758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 648 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 648 participants in total. It began in 2024-02-07 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Suzanne McCluskey, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05373758 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05373758 currently recruiting?
Yes, NCT05373758 is actively recruiting participants. Contact the research team at smccluskey@mgh.harvard.edu for enrollment information.
Where is the NCT05373758 trial being conducted?
This trial is being conducted at Durban, South Africa, Mbarara, Uganda, Mbarara, Uganda.
Who is sponsoring the NCT05373758 clinical trial?
NCT05373758 is sponsored by Massachusetts General Hospital. The principal investigator is Suzanne McCluskey, MD at Massachusetts General Hospital. The trial plans to enroll 648 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.