Evaluating management strategies for HIV treatment failure in Sub-Saharan Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.