RecruitingPhase 3NCT06747507

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

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


Sponsor

University of Nairobi

Enrollment

392 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

The Ndovu RCT is studying the best treatment strategy for people living with HIV whose virus has developed resistance to a first-line medication called dolutegravir. The study is comparing different antiretroviral drug combinations to find the most effective approach when resistance develops. **You may be eligible if...** - You are at least 3 years old - You are already enrolled in the Ndovu cohort study - Your HIV viral load is 200 copies/mL or higher (meaning the virus is not fully suppressed) - Your HIV has developed at least one specific resistance mutation to dolutegravir - You are able to provide informed consent (or a guardian can consent for you) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are taking medications that cannot be safely combined with the study drugs - You have a serious active HIV-related illness (WHO stage 3 or 4) that would prevent you from being assigned to either treatment arm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDolutegravir Pill

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

DRUGDarunavir+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

View Full Details on ClinicalTrials.gov

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NCT06747507


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