Managing dolutegravir resistance in HIV treatment
Investigating the Optimal Management of Dolutegravir Resistance: a Multi-country Cohort Study
This study is testing if staying on a dolutegravir-based HIV treatment helps people who haven't been able to lower their viral load and whether it leads to drug resistance, while also offering support to help them stick to their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6600 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | University of Nairobi Academic / other |
| Locations | 9 sites (Kisumu and 8 other locations) |
| Trial ID | NCT06762054 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of continuing dolutegravir-based antiretroviral therapy in individuals with HIV-1 who have experienced virologic failure. It aims to fill the knowledge gap regarding viral suppression rates among patients who have not switched their treatment regimen despite high viral loads. The study will also evaluate the emergence of drug-resistant mutations associated with dolutegravir and their impact on treatment outcomes. Enhanced adherence counseling will be provided to participants to improve their viral suppression rates.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 1 year and older who have been on a dolutegravir-based ART regimen for at least six months and have a recent HIV-1 RNA level greater than 1,000 copies/mL.
Not a fit: Patients who have switched their ART regimen due to confirmed or suspected treatment failure or those on concomitant NNRTI or PI medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with HIV-1 who are experiencing treatment failure on dolutegravir.
How similar studies have performed: While this approach is not widely tested, it aligns with emerging practices in managing dolutegravir resistance, suggesting potential for success based on preliminary findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kisumu and 8 other locations
- Jaramogi Oginga Odinga Teaching and Referral Hospital — Kisumu, Kenya (Recruiting)
- Bomu Hospital — Mombasa, Kenya (Not_yet_recruiting)
- Kenyatta National Hospital — Nairobi, Kenya (Recruiting)
- Butha-Buthe District Hospital — Butha-Buthe, Lesotho (Recruiting)
- Mokhotlong District Hospital — Mokhotlong, Lesotho (Recruiting)
- CS Ponta Gea — Beira, Sofala, Mozambique (Not_yet_recruiting)
- CS Machava II — Maputo, Mozambique (Not_yet_recruiting)
- CS Ndlavela — Maputo, Mozambique (Not_yet_recruiting)
- MUHAS Clinical Trial Unit — Dar es Salaam, Tanzania (Not_yet_recruiting)
Study contacts
- Principal investigator: Loice A Ombajo, MMed, MSc — University of Nairobi
- Study coordinator: Joseph Nkuranga, MBChB, MSc
- Email: dnkuranga@uonbi.ac.ke
- Phone: +254737223988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.