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Official title A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
ClinicalTrials.gov ID: NCT05373758
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join 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
You likely can't join 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durban, South Africa
- Mbarara, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durban, South Africa; Mbarara, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.