Identifying drug resistance in HIV patients failing Dolutegravir treatment
HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir-based 1st, 2nd or 3rd Line Regimens: the International Epidemiological Databases to Evaluate AIDS (IeDEA)
This study is testing if people with HIV who aren't responding to their Dolutegravir treatment have any new drug-resistance mutations in their virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2600 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Locations | 22 sites (Buenos Aires and 21 other locations) |
| Trial ID | NCT06285110 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals living with HIV who are experiencing virologic failure while on a Dolutegravir-based antiretroviral treatment regimen. Participants will undergo a single study visit for blood collection, where the HIV virus will be sequenced to identify drug-resistance mutations. The study aims to uncover novel mutations associated with virologic failure and assess risk factors for developing drug resistance. Conducted across 15-20 countries, it leverages the International epidemiology Databases to Evaluate AIDS (IeDEA) cohort for comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates include adults and adolescents on a Dolutegravir-based regimen who have experienced virologic failure.
Not a fit: Patients who are not on a Dolutegravir-based regimen or who have not experienced virologic failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for HIV patients experiencing drug resistance.
How similar studies have performed: Other studies have shown success in identifying drug resistance mutations in HIV, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older and adolescents (10-17 years) * On any DTG-based ART regimen * Who develop virologic failure (VF) defined as a VL \>1000 copies/mL (single or confirmed measurement), * and have signed the informed consent. Exclusion Criteria: * No Informed Consent
Where this trial is running
Buenos Aires and 21 other locations
- Centro Medico Huesped — Buenos Aires, Argentina (Recruiting)
- Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz — Rio De Janeiro, Brazil (Recruiting)
- Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou) — Bobo-Dioulasso, Burkina Faso (Recruiting)
- National Centre for HIV/AIDS, Dermatology and STDs (NCHADS) — Phnom Penh, Cambodia (Recruiting)
- Regional Hospital Limbe — Limbe, Cameroon (Recruiting)
- Hospital Jamot — Yaounde, Cameroon (Recruiting)
- Centre de Traitement Ambulatoire — Brazzaville, Congo (Recruiting)
- Centre de Traitement Ambulatoire — Pointe Noire, Congo (Recruiting)
- ACONDA Centre de Prise en Charge et de Formation (CePReF) — Abidjan, Côte D'Ivoire (Recruiting)
- Centre médical de suivi des donneurs de sang, CNTS — Abidjan, Côte D'Ivoire (Recruiting)
- Moi University, AMPATH — Eldoret, Kenya (Recruiting)
- Lighthouse clinic — Lilongwe, Malawi (Recruiting)
- Martin Preuss Centre — Lilongwe, Malawi (Recruiting)
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City, Mexico (Recruiting)
- Research for Development, Einstein-Rwanda Research and Capacity Building Program — Kigali, Rwanda (Recruiting)
- National Institute for Medical Research (NIMR) — Kisesa, Tanzania (Recruiting)
- HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC) — Bangkok, Thailand (Recruiting)
- Ramathibodi Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
- Masaka Regional Referral Hospital / AHF Uganda Cares — Masaka, Uganda (Recruiting)
- Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST) — Mbarara, Uganda (Recruiting)
- Centre for Infectious Disease Research Zambia (CIDRZ) — Lusaka, Zambia (Recruiting)
- Newlands Clinic — Harare, Zimbabwe (Recruiting)
Study contacts
- Principal investigator: Richard Lessells, Dr. — KwaZulu-Natal Research Innovation & Sequencing Platform, University of KwaZulu-Natal, South Africa
- Study coordinator: Matthias Egger, Prof.Dr.
- Email: matthias.egger@unibe.ch
- Phone: +41 31 684 35 11
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.