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RECRUITING
NCT06762054

Investigating the Optimal Management of Dolutegravir Resistance

Sponsor: University of Nairobi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

OBSERVATIONAL

Enrollment

6600

Start Date

2025-03-03

Completion Date

2026-10

Last Updated

2025-09-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

Continue DTG-based antiretroviral therapy

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

BEHAVIORAL

Enhanced 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