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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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Medico Huesped
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Buenos AiresArgentinaUnknown status
Hopital de Jour du Centre Hospitalier Universitaire (CHU Souro Sanou)
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Bobo-DioulassoBurkina FasoUnknown status
Instituto Nacional de Infectiologia Evandro Chagas - Fiocruz
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Rio de JaneiroBrazilUnknown status
Centre médical de suivi des donneurs de sang, CNTS
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AbidjanCôte d’IvoireUnknown status
ACONDA Centre de Prise en Charge et de Formation (CePReF)
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AbidjanCôte d’IvoireUnknown status
Regional Hospital Limbe
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LimbeCameroonUnknown status
Hospital Jamot
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YaoundéCameroonUnknown status
Moi University, AMPATH
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EldoretKenyaUnknown status
National Centre for HIV/AIDS, Dermatology and STDs (NCHADS)
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Phnom PenhCambodiaUnknown status
Martin Preuss Centre
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LilongweMalawiUnknown status
Lighthouse clinic
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LilongweMalawiUnknown status
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Mexico CityMexicoUnknown status
Research for Development, Einstein-Rwanda Research and Capacity Building Program
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KigaliRwandaUnknown status
Ramathibodi Hospital, Mahidol University
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BangkokThailandUnknown status
HIV-NAT/Thai Red Cross AIDS Research Center (TRCARC)
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BangkokThailandUnknown status
National Institute for Medical Research (NIMR)
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KisesaTanzaniaUnknown status
Masaka Regional Referral Hospital / AHF Uganda Cares
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MasakaUgandaUnknown status
Mbarara University of Science and Technology / Mbarara ISS Clinic (MUST)
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MbararaUgandaUnknown status
Centre for Infectious Disease Research Zambia (CIDRZ)
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LusakaZambiaUnknown status
Newlands Clinic
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HarareZimbabweUnknown status
Centre de Traitement Ambulatoire
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BrazzavilleRepublic of the CongoUnknown status
Centre de Traitement Ambulatoire
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Pointe-NoireRepublic of the CongoUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.