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Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
Sponsor: University of Nairobi
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
Dolutegravir Pill
Dose will be based on weight; brand names will be as supplied through the respective national programs
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