Investigating the Optimal Management of Dolutegravir Resistance
Recruiting now
Conditions studied: HIV-1-infection
In brief
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.
Key facts
- Study ID
- NCT06762054
- Run by
- University of Nairobi
- People needed
- 6600
- Starts
- 2025-03-03
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-09-05
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able and willing to provide informed consent (assent as appropriate and legal guardian consent if < 18 years)
- Age ≥ 1 years
- Documented HIV-1 infection as confirmed by national HIV testing standards at the respective study sites
- On a DTG-based ART regimen for at least six months
- Most recent HIV-1 RNA ≥ 1,000 copies/mL within 3 months prior to enrolment, taken after at least 6 months on current ART regimen
You may not qualify if…
- Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen
- Any reason which, in the investigator's opinion, will significantly prevent the collection of viral load levels such as relocation to another area outside of the trial sites or imminent death
- Concomitant NNRTI or PI while on DTG
Where it is running
- Jaramogi Oginga Odinga Teaching and Referral Hospital — Kisumu, Kenya (enrolling)
- Kenyatta National Hospital — Nairobi, Kenya (enrolling)
- Butha-Buthe District Hospital — Butha-Buthe, Lesotho (enrolling)
- Mokhotlong District Hospital — Mokhotlong, Lesotho (enrolling)
- MUHAS Clinical Trial Unit — Dar es Salaam, Tanzania
- CS Ponta Gea — Beira, Sofala, Mozambique
- Bomu Hospital — Mombasa, Kenya
- CS Machava II — Maputo, Mozambique
- CS Ndlavela — Maputo, Mozambique
Full record on ClinicalTrials.gov
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