Evaluating management strategies for HIV treatment failure 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
This study is testing different treatment options for people with HIV in Uganda and South Africa who aren't responding well to their current medication, to see which approach helps them lower their viral load the best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 648 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Durban and 2 other locations) |
| Trial ID | NCT05373758 on ClinicalTrials.gov |
What this trial studies
The RESOLVE trial is a randomized clinical trial aimed at finding the best approach to manage virologic failure in patients on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in Uganda and South Africa. Participants aged 15 and older, who have experienced high viral loads while on TLD, will be randomly assigned to one of three treatment strategies: Standard of Care, Individualized Care based on resistance testing, or an Immediate Switch to a different ART regimen. The primary goal is to achieve viral suppression to less than 50 copies/mL within 48 weeks. The trial will follow participants for one year with regular assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 and above with HIV who have had two viral load measurements over 1,000 copies/mL while on TLD for at least 12 months.
Not a fit: Patients who have known virologic failure on protease inhibitors or have been exposed to integrase strand transfer inhibitors other than dolutegravir may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients experiencing virologic failure on TLD.
How similar studies have performed: Other studies have shown success with similar approaches to managing virologic failure, indicating that this trial builds on established methodologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durban and 2 other locations
- RK Khan Hospital Clinic — Durban, South Africa (Recruiting)
- Mbarara City Clinic — Mbarara, Uganda (Recruiting)
- Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic — Mbarara, Uganda (Recruiting)
Study contacts
- Principal investigator: Suzanne McCluskey, MD — Massachusetts General Hospital
- Study coordinator: Suzanne McCluskey, MD
- Email: smccluskey@mgh.harvard.edu
- Phone: 617-726-9488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.