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

RecruitingNA

Sponsor: Massachusetts General Hospital

Conditions: HIV Infections, AIDS, Virologic Failure

Interventions: Standard of Care treatment strategy, Individualized Care treatment strategy, Immediate Switch

Countries: South Africa, Uganda

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 overview

Sex: ALL

Age: 15 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (3)

Durban, South Africa
Mbarara, Uganda
Mbarara, Uganda