Actively Recruiting
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
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
- 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
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
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
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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