Actively Recruiting

Age: 1Year +
All Genders
NCT06762054

Investigating the Optimal Management of Dolutegravir Resistance

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

6600

Participants Needed

9

Research Sites

82 weeks

Total Duration

On this page

Sponsors

U

University of Nairobi

Lead Sponsor

I

Instituto Nacional de Saúde, Mozambique

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Investigating the Optimal Management of Dolutegravir Resistance

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

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
  • Documented HIV-1 infection confirmed by national HIV testing standards
  • On a dolutegravir-based ART regimen for at least six months
  • Most recent HIV-1 RNA viral load of 1,000 copies/mL or higher within 3 months prior to enrollment, measured after at least six months on current ART
Not Eligible

You will not qualify if you...

  • Has switched ART regimen for confirmed or suspected HIV treatment failure while on protease inhibitor or integrase strand transfer inhibitor regimens
  • Any condition that would prevent collection of viral load data, such as moving out of study area or expected death
  • Using non-nucleoside reverse transcriptase inhibitor or protease inhibitor concurrently while on dolutegravir

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

Actively Recruiting

2

Bomu Hospital

Mombasa, Kenya

Not Yet Recruiting

3

Kenyatta National Hospital

Nairobi, Kenya, 00100

Actively Recruiting

4

Butha-Buthe District Hospital

Butha-Buthe, Lesotho

Actively Recruiting

5

Mokhotlong District Hospital

Mokhotlong, Lesotho

Actively Recruiting

6

CS Ponta Gea

Beira, Sofala, Mozambique

Not Yet Recruiting

7

CS Machava II

Maputo, Mozambique

Not Yet Recruiting

8

CS Ndlavela

Maputo, Mozambique

Not Yet Recruiting

9

MUHAS Clinical Trial Unit

Dar es Salaam, Tanzania

Not Yet Recruiting

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Research Team

J

Joseph Nkuranga, MBChB, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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