GIVE MOVE - Genotype-Informed Versus Empiric Management of VirEmia: A Randomised Clinical Trial

Background

HIV-1-positive children and adolescents receiving antiretroviral therapy (ART) suffer high rates of treatment failure, predominantly caused by poor adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT), this diagnostic tool is not available in most low-income settings. For patients with a high viral load while on first-line ART, World Health Organisation guidelines recommend several months of adherence counselling followed by repeated viral load testing, with a sustained high viral load triggering a switch to an empirically selected second-line ART regimen.

Methods

We will assess the clinical impact of GRT in an open-label randomised clinical trial enrolling 276 children and adolescents with an unsuppressed viral load (≥400 c/mL) while on a first-line ART regimen. Participants will be enrolled in Lesotho (four hospitals in three districts) and Tanzania (one hospital) and will be randomised to a control or intervention arm in a 1:1 allocation. The control arm will receive modified standard care, consisting of at least three sessions of adherence counselling followed by a follow-up viral load result which, if again unsuppressed (≥400 c/mL), will trigger a switch to an empirically selected second-line regimen. By contrast, the intervention arm will receive GRT (Sanger sequencing) and GRT-informed onward therapy. We will compare clinical outcomes (mortality, morbidity, viral suppression) at nine months. In a nested study, we will assess the cost and cost-effectiveness of the intervention.

Discussion

The GIVE MOVE trial will assess whether early resistance testing could improve clinical outcomes for children and adolescents with viremia while receiving ART.

Funding

Fondation Botnar (REG-19-008), Swiss National Science Foundation (PCEFP3_181355)

More information

Trial registration: ClinicalTrials.gov (NCT04233242), registered 18 January 2020

Trial website: www.givemove.org

Protocol publication: BMC Infectious Diseases, 19 October 2020

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