NCT06762054Active, not recruiting
Investigating the Optimal Management of Dolutegravir Resistance
Investigating the Optimal Management of Dolutegravir Resistance: a Multi-country Cohort Study
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 6624 (actual)
- First submitted
- 18 Dec 2024
- Start date
- 3 Mar 2025
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- University of Nairobi
- Diseases
- HIV
- NCT number
- NCT06762054
What you commit to
- Study type: Observational
- Participants enrolled: 6624
- From 3 Mar 2025 to the primary completion date, 15 Feb 2027
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant NNRTI or PI while on DTG
Other illness
- Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen
Other
- 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
Who the study is looking for
- 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
Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jaramogi Oginga Odinga Teaching and Referral Hospital Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
| Bomu Hospital Coordinator of this site? Confirm its status | Mombasa | Kenya | Unknown status |
| Kenyatta National Hospital Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
| Butha Buthe District Hospital Coordinator of this site? Confirm its status | Butha-Buthe | Lesotho | Unknown status |
| Mokhotlong District Hospital Coordinator of this site? Confirm its status | Mokhotlong | Lesotho | Unknown status |
| CS Ponta Gea Coordinator of this site? Confirm its status | Beira | Mozambique | Unknown status |
| CS Machava II Coordinator of this site? Confirm its status | Maputo | Mozambique | Unknown status |
| CS Ndlavela Coordinator of this site? Confirm its status | Maputo | Mozambique | Unknown status |
| MUHAS Clinical Trial Unit Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.