NCT06285110Completed
HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen
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)
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1103 (actual)
- First submitted
- 8 May 2023
- Start date
- 13 Jun 2022
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- University of Bern
- Diseases
- HIV
- NCT number
- NCT06285110
What you commit to
- Study type: Observational
- Participants enrolled: 1103
- From 13 Jun 2022 to the primary completion date, 31 Aug 2025
- 22 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No Informed Consent
Who the study is looking for
- 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.
Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Medico Huesped Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou) Coordinator of this site? Confirm its status | Bobo-Dioulasso | Burkina Faso | Unknown status |
| Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Centre médical de suivi des donneurs de sang, CNTS Coordinator of this site? Confirm its status | Abidjan | Côte d’Ivoire | Unknown status |
| ACONDA Centre de Prise en Charge et de Formation (CePReF) Coordinator of this site? Confirm its status | Abidjan | Côte d’Ivoire | Unknown status |
| Regional Hospital Limbe Coordinator of this site? Confirm its status | Limbe | Cameroon | Unknown status |
| Hospital Jamot Coordinator of this site? Confirm its status | Yaoundé | Cameroon | Unknown status |
| Moi University, AMPATH Coordinator of this site? Confirm its status | Eldoret | Kenya | Unknown status |
| National Centre for HIV/AIDS, Dermatology and STDs (NCHADS) Coordinator of this site? Confirm its status | Phnom Penh | Cambodia | Unknown status |
| Martin Preuss Centre Coordinator of this site? Confirm its status | Lilongwe | Malawi | Unknown status |
| Lighthouse clinic Coordinator of this site? Confirm its status | Lilongwe | Malawi | Unknown status |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Research for Development, Einstein-Rwanda Research and Capacity Building Program Coordinator of this site? Confirm its status | Kigali | Rwanda | Unknown status |
| Ramathibodi Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| National Institute for Medical Research (NIMR) Coordinator of this site? Confirm its status | Kisesa | Tanzania | Unknown status |
| Masaka Regional Referral Hospital / AHF Uganda Cares Coordinator of this site? Confirm its status | Masaka | Uganda | Unknown status |
| Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST) Coordinator of this site? Confirm its status | Mbarara | Uganda | Unknown status |
| Centre for Infectious Disease Research Zambia (CIDRZ) Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
| Newlands Clinic Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
| Centre de Traitement Ambulatoire Coordinator of this site? Confirm its status | Brazzaville | Republic of the Congo | Unknown status |
| Centre de Traitement Ambulatoire Coordinator of this site? Confirm its status | Pointe-Noire | Republic of the Congo | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.