GIVE MOVE - Genotype-Informed Versus Empiric Management Of VirEmia: an Open-Label 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) to inform onward treatment, availability of this diagnostic tool is limited in most low-income settings. For patients with a high viral load while receiving 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

The clinical impact of GRT is assessed in an open-label randomised clinical trial enrolling 276 children and adolescents with an unsuppressed viral load (≥400 copies/mL) while receiving ART. Participants are enrolled in several sites in Lesotho and Tanzania and are randomised to a control or intervention arm in a 1:1 allocation. The control arm receives modified standard care, consisting of at least three sessions of adherence counselling followed by a follow-up viral load result to inform onward treatment. By contrast, the intervention arm receives GRT, an Expert Committee recommendation based on the GRT result, and GRT-informed onward therapy. This trial compares clinical outcomes (mortality, morbidity, viral suppression) at nine months. A nested study assesses the cost and cost-effectiveness of the intervention.

Discussion

The GIVE MOVE trial aims to 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

Brown J.A, Ringera I, Luoga E, Cheleboi M, Kimera N, Muhairwe J, Kayembe B.P, Molapo Hlasoa M, Kabundi L, Yav C.W.D, Mothobi B, Thahane L, Amstutz A, Bachmann N, Mollel G.J, Bresser M, Glass T.R, Paris D.H, Klimkait T, Weisser M, Labhardt N.D. Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania. BMC Infect Dis. 2020;20:773. DOI: 10.1186/s12879-020-05491-9

Contact

• https://clinicaltrials.gov/ct2/show/NCT04233242