RecruitingNCT06762054

Investigating the Optimal Management of Dolutegravir Resistance

Investigating the Optimal Management of Dolutegravir Resistance: a Multi-country Cohort Study


Sponsor

University of Nairobi

Enrollment

6,600 participants

Start Date

Mar 3, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen. The study will also assess the emergence of DTG-associated drug-resistant mutations and their impact on viral suppression.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is investigating the best way to manage HIV in people whose virus has become resistant to a common HIV drug called dolutegravir (DTG). It aims to find the most effective treatment switch strategy. **You may be eligible if...** - You are 1 year of age or older (with guardian consent for minors) - You have confirmed HIV-1 infection - You have been on a dolutegravir-containing treatment regimen for at least 6 months - Your most recent HIV viral load is 1,000 copies/mL or higher (meaning your current treatment is not controlling the virus) **You may NOT be eligible if...** - You previously switched HIV treatment because of confirmed or suspected treatment failure on a protease inhibitor or integrase inhibitor regimen - You are currently taking an NNRTI or PI-based regimen alongside dolutegravir - You are unlikely to complete follow-up (e.g., planning to relocate away from the study site) 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

DRUGContinue DTG-based antiretroviral therapy

Participants will continue on DTG-based ART after enrollment for up to 12 months

BEHAVIORALEnhanced adherence counselling

Participants with VL ≥200 copies/mL will undergo enhanced adherence counselling


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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NCT06762054


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