What is this study trying to find out about HIV-1 infection?

This study aims to understand how well people with HIV-1 infection maintain viral suppression while continuing dolutegravir-based treatment after experiencing high viral loads. Researchers want to learn about the development of drug-resistant mutations and their impact on treatment. The study is led by the University of Nairobi and includes participants from several countries.

Who may be eligible for this HIV-1 infection clinical trial?

People aged 1 year and older who have confirmed HIV-1 infection and have been on a dolutegravir-based antiretroviral therapy for at least six months may be eligible. Participants must have a recent viral load of 1,000 copies/mL or higher. Anyone who has switched treatment due to failure with certain drug classes may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV-1 infection clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel expenses for attending visits may vary and are not guaranteed to be covered. Participants should consider these factors when deciding to join.

Actively Recruiting

Age: 1Year +

All Genders

ID06762054

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

Led by University of Nairobi · Updated on 2025-09-05

6600

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying people living with HIV-1 infection who are on dolutegravir DTG-based antiretroviral therapy ART but have a viral load above 1,000 copiesmL after at least six months of treatment. The goal is to understand viral suppression rates and the emergence of DTG-associated drug-resistant mutations in these individuals. This multi-country prospective observational study takes place in Kenya, Mozambique, Tanzania, and Lesotho, addressing gaps in data about managing virologic failure without changing the ART regimen. Participants will continue their DTG-based ART for up to 12 months while receiving enhanced adherence counseling if their viral load remains above 200 copiesmL. Study visits and viral load testing happen at enrollment and every three months during the active follow-up period. Enhanced adherence counseling includes at least three sessions per visit to support medication adherence and address other causes of viral increase. The study also collects routine program data for up to 24 months to assess how well viral suppression lasts over time. During the study, participants undergo viral load testing, counseling, and assessments at regular intervals. Researchers will analyze viral suppression rates at 6 and 12 months and evaluate factors that predict suppression or the development of drug resistance. They will also monitor the patterns and timing of drug-resistant mutations and opportunistic infections. The study plans to enroll 6,600 participants and may invite eligible individuals to join a nested randomized clinical trial focusing on managing drug resistance.

CONDITIONS

Brief Title

Investigating the Optimal Management of Dolutegravir Resistance

Who Can Participate

Age: 1Year +

All Genders

Eligibility Criteria

You may qualify if you...

Able and willing to provide informed consent (assent as appropriate and legal guardian consent if under 18 years)
Age 1 year or older
Confirmed HIV-1 infection according to national testing standards
On a dolutegravir-based antiretroviral therapy regimen for at least six months
Most recent HIV-1 RNA viral load of 1,000 copies/mL or higher within 3 months before enrollment, taken after at least 6 months on current ART regimen

You will not qualify if you...

Has switched ART regimen due to confirmed or suspected treatment failure on protease inhibitor or integrase strand transfer inhibitor-based regimen
Any condition likely to prevent collection of viral load data such as relocation outside trial sites or imminent death
Concurrent use of non-nucleoside reverse transcriptase inhibitors or protease inhibitors while on dolutegravir

Research Team

Joseph Nkuranga, MBChB, MSc

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