NCT06762054 Investigating the Optimal Management of Dolutegravir Resistance
| NCT ID | NCT06762054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nairobi |
| Condition | HIV-1-infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,600 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,600 participants in total. It began in 2025-03-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Loice A Ombajo, MMed, MSc
PRINCIPAL INVESTIGATOR
University of Nairobi
Frequently Asked Questions
Who can join the NCT06762054 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06762054 currently recruiting?
Yes, NCT06762054 is actively recruiting participants. Contact the research team at dnkuranga@uonbi.ac.ke for enrollment information.
Where is the NCT06762054 trial being conducted?
This trial is being conducted at Kisumu, Kenya, Mombasa, Kenya, Nairobi, Kenya, Butha-Buthe, Lesotho and 5 additional locations.
Who is sponsoring the NCT06762054 clinical trial?
NCT06762054 is sponsored by University of Nairobi. The principal investigator is Loice A Ombajo, MMed, MSc at University of Nairobi. The trial plans to enroll 6,600 participants.
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