Investigating the Optimal Management of Dolutegravir Resistance
Recruiting · NCT06762054 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Nairobi
View the official record on ClinicalTrials.gov →Interventions studied
Continue DTG-based antiretroviral therapyEnhanced adherence counselling
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.
Who can take part
Age range
1 Year and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
9 locations listed.
- Butha-Buthe District Hospital - Butha-Buthe, Lesotho
- MUHAS Clinical Trial Unit - Dar es Salaam, Tanzania
- Jaramogi Oginga Odinga Teaching and Referral Hospital - Kisumu, Kenya
- CS Machava II - Maputo, Mozambique
- CS Ndlavela - Maputo, Mozambique
- Mokhotlong District Hospital - Mokhotlong, Lesotho
- Bomu Hospital - Mombasa, Kenya
- Kenyatta National Hospital - Nairobi, Kenya
- CS Ponta Gea - Beira, Sofala, Mozambique