Investigating the Optimal Management of Dolutegravir Resistance
Trial Parameters
Brief Summary
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 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