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Recruiting NCT05373758

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

No phase Interventional HIV Infections AIDS Virologic Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care treatment strategy, Individualized Care treatment strategy, Immediate Switch.
Who it may be relevant to
Registry conditions: HIV Infections, AIDS, Virologic Failure. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Africa, Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and above who have had two HIV-1 RNA viral load results \>1,000 copies/mL while on TLD and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms: a) Standard of Care (regimen guided by genotypic resistance tests and care as per guidelines in Uganda; and with regimen selection and possible genotypic resistance testing (GRT) and care as per guidelines in South Africa), 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic, prior exposure to non-nucleoside reverse transcriptase inhibitors, and virologic failure history. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to \<50 copies/mL at 48 weeks using the FDA snapshot definition.

Interventions

  • Other Standard of Care treatment strategy
    Management of virologic failure on TLD using the Standard of Care strategy
  • Other Individualized Care treatment strategy
    Management of virologic failure on TLD using the Individualized Care strategy
  • Other Immediate Switch
    Management of virologic failure on TLD using the Immediate Switch strategy

Primary outcome measures

  • Viral suppression at 48 weeks [Time frame: 48 weeks post-enrollment (visit window spanning 42 to 54 weeks post-enrollment)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Uganda · 2 centers
  • Mbarara City Clinic — Mbarara
  • Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic — Mbarara
South Africa · 1 center
  • RK Khan Hospital Clinic — Durban

Identifiers

NCT: NCT05373758 · 2022P001193 · R01AI167699

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗