NCT04233242: GIVE MOVE

Genotype-Informed Versus Empiric Management of VirEmia

Completed NA Last updated 25 September 2024

What this trial tests

NA trial testing Clinical management informed by HIV-1 genotypic resistance testing in HIV-1-infection in 286 participants. Completed in 8 July 2023.

Timeline

3 March 2020

Primary endpoint
15 March 2023

8 July 2023

Quick facts

Lead sponsor	Swiss Tropical & Public Health Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	286
Start date	3 March 2020
Primary completion	15 March 2023
Estimated completion	8 July 2023
Sites	10 locations across Tanzania, Lesotho

Drugs / interventions tested

• Clinical management informed by HIV-1 genotypic resistance testing

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Swiss Tropical & Public Health Institute

Who can join

Adults 6 Months to 19, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal adherence to therapy and/or viral drug resistance. While high-income countries routinely use genotypic resistance testing (GRT) to determine which drug combinations are likely to be effective, this diagnostic tool is relatively costly and labour-intensive and is not routinely available in most resource-limited settings.

GIVE MOVE is a multi-country (Lesotho, Tanzania) randomised clinical trial assessing if rapid GRT after detecting an unsuppressed viral load improves the clinical management and thus health outcomes for children and adolescents living with HIV. Children and adolescents with an unsuppressed viral load despite ART are enrolled and randomly allocated to a control or an intervention arm (50% of participants in each arm). The control arm receives care according to the current standard of care, consisting of three sessions of enhanced adherence counselling at monthly intervals, followed by a second viral load test. Onward treatment is informed by the outcome of this viral load test alongside empirical guidelines and clinical judgement. The intervention arm receives GRT and GRT-informed onward therapy. Participants in the intervention arm also receive three sessions of enhanced adherence counselling, which is informed by GRT results (i.e., if no drug resistance is detected, there is a high chance of suboptimal adherence to ART and this can be directly addressed).

This trial will assess if the rapid provision of GRT improves participants' health outcomes at 9 months after enrolment. A nested study will assess the cost and cost-effectiveness of GRT. Thus, this trial will provide evidence on whether the provision of GRT for children and adolescents with HIV should be prioritised in resource-limited settings.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Brown JA, Ringera I, Luoga E, Cheleboi M, et al · · 2020 · cited 3× · PMID 33076866 · DOI 10.1186/s12879-020-05491-9
2. Resistance-informed versus empirical management of viraemia in children and adolescents with HIV in Lesotho and Tanzania (GIVE MOVE trial): a multisite, open-label randomised controlled trial.
   Brown JA, Ringera IK, Luoga E, Bresser M, et al · · 2024 · cited 2× · PMID 39030062 · DOI 10.1016/s2214-109x(24)00183-9
3. HIV drug resistance amongst children and adolescents with viraemia in Lesotho and Tanzania: a nested analysis in the GIVE MOVE trial.
   Schönenberger CM, Haenggi K, Ringera IK, Luoga E, et al · · 2026 · PMID 41793741 · DOI 10.1093/jac/dkag070