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RECRUITING
NCT06747507
PHASE3

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

Sponsor: University of Nairobi

View on ClinicalTrials.gov

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.

Official title: Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

INTERVENTIONAL

Enrollment

392

Start Date

2025-09-01

Completion Date

2027-07

Last Updated

2025-09-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dolutegravir Pill

Dose will be based on weight; brand names will be as supplied through the respective national programs

DRUG

Darunavir+Ritonavir

Dose will be based on weight

Locations (9)

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

Bomu Hospital

Mombasa, Kenya

Kenyatta National Hospital

Nairobi, Kenya

Butha-Buthe District Hospital

Butha-Buthe, Lesotho

Mokhotlong District Hospital

Mokhotlong, Lesotho

CS Ponta Gea

Beira, Sofala, Mozambique

CS Machava II

Maputo, Mozambique

CS Ndlavela

Maputo, Mozambique

MUHAS Clinical Trial Unit

Dar es Salaam, Tanzania