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Investigating the Optimal Management of Dolutegravir Resistance

NCT06762054

RecruitingN/A

Sponsor: University of Nairobi

Conditions: HIV-1-infection

Interventions: Continue DTG-based antiretroviral therapy, Enhanced adherence counselling

Countries: Kenya, Lesotho, Mozambique, Tanzania

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.

Eligibility overview

Sex: ALL

Age: 1 Year to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (9)

Kisumu, Kenya
Mombasa, Kenya
Nairobi, Kenya
Butha-Buthe, Lesotho
Mokhotlong, Lesotho
Beira, Sofala, Mozambique
Maputo, Mozambique
Maputo, Mozambique
Dar es Salaam, Tanzania