Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

Phase 3 Recruiting 392 enrolled University of Nairobi Instituto Nacional de Saúde, Mozambique · collab London School of Hygiene and Tropical Medicine · collab Muhimbili University of Health and Allied Sciences · collab SolidarMed · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.

Timeline

Start: 2025-09-01
Primary completion: 2026-12
Completion: 2027-07

Publications

Ombajo LA, Nkuranga J, Penner J, Kamau EW, Ismael N, Munseri P, Ayakaka I, Labhardt N, Wamalwa D, Ramgi P, Chissumba RM, Wagude J, Bakari M, Omodi V, Otieno E, Abuogi L, Patel R, Opondo C, Grint D, King'wara L, Macharia A, Mulwa A, Amoth P; Ndovu study group. The dolutegravir failure cohort: A multi-country longitudinal cohort with a randomised clinical trial of continued dolutegravir versus switch to darunavir in people with viraemia while on dolutegravir in Sub-Saharan Africa (The Ndovu Study) protocol. PLoS One. 2026 Mar 13;21(3):e0330792. doi: 10.1371/journal.pone.0330792. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Darunavir	Small molecule	—	—
Subject	Dolutegravir	Other / unclassified	—	—
Comparator	Ritonavir	Other / unclassified	—	—

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

Summary

Timeline

Publications

Drugs

Indications