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Investigating the Optimal Management of Dolutegravir Resistance

NCT06762054 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 6600

Last updated 2025-09-05

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Instituto Nacional de Saúde, Mozambique

    collaborator OTHER_GOV

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • SolidarMed

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • University of Nairobi

    lead OTHER

Principal Investigators

  • Loice A Ombajo, MMed, MSc · University of Nairobi

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Kenya
  • Lesotho
  • Mozambique
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762054 on ClinicalTrials.gov