Clinical trialNCT01302847CompletedPhase 1/PHASE2Interventional

Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment181HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy (OBT) in HIV-1 infected infants, children, and adolescents.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrew Wiznia, M.D.
Jacobi Medical Center
Study Chair
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Theodore Ruel, M.D.
University of California, San Francisco
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

33 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Botswana

Gaborone Crs (site Id: 12701)
Gaborone, South-East District, Botswana
Molepolole Crs (site Id: 12702)
Gaborone, Botswana

Brazil

Som Federal University Minas Gerais Brazil Nichd Crs (site Id: 5073)
Belo Horizonte, Minas Gerais, Brazil
Hosp. Geral de Nova Igaucu Brazil Nichd Crs (site Id: 5097)
Rio de Janeiro, Brazil
Hospital Federal Dos Servidores Do Estado Nichd Crs (site Id: 5072)
Rio de Janeiro, Brazil
Instituto de Puericultura E Pediatria Martagao Gesteira - Ufrj Nichd Crs (site Id: 5071)
Rio de Janeiro, Brazil
Univ. of Sao Paulo Brazil Nichd Crs (site Id: 5074)
São Paulo, Brazil

Kenya

Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho Crs (site Id: 5121)
Kericho, Kenya

South Africa

Wits Rhi Shandukani Research Centre Crs (site Id: 8051)
Johannesburg, Gauteng, South Africa
Umlazi Crs (site Id: 30300)
Durban, KwaZulu-Natal, South Africa
Famcru Crs (site Id: 8950)
Tygerberg, Western Cape, South Africa

Tanzania

Kilimanjaro Christian Medical Centre (kcmc) (site Id: 5118)
Moshi, Tanzania

Thailand

Siriraj Hospital, Mahidol University Nichd Crs (site Id: 5115)
Bangkok, Bangkoknoi, Thailand
Chiang Mai University Hiv Treatment (cmu Hiv Treatment) Crs (site Id: 31784)
Chiang Mai, Thailand
Chiangrai Prachanukroh Hospital Nichd Crs (site Id: 5116)
Chiang Mai, Thailand

United States

University of California, Uc San Diego Crs- Mother-Child-Adolescent Hiv Program (site Id: 4601)
La Jolla, California, United States
Miller Children'S Hosp. Long Beach Ca Nichd Crs (site Id: 5093)
Long Beach, California, United States
David Geffen School of Medicine at Ucla Nichd Crs (site Id: 5112)
Los Angeles, California, United States
Univ. of California San Francisco Nichd Crs (site Id: 5091)
San Francisco, California, United States
Univ. of Colorado Denver Nichd Crs (site Id: 5052)
Aurora, Colorado, United States
Howard Univ. Washington Dc Nichd Crs (site Id: 5044)
Washington D.C., District of Columbia, United States
South Florida Cdtc Ft Lauderdale Nichd Crs (site Id: 5055)
Fort Lauderdale, Florida, United States
Usf - Tampa Nichd Crs (site Id: 5018)
Tampa, Florida, United States
Lurie Children'S Hospital of Chicago (lch) Crs (site Id: 4001)
Chicago, Illinois, United States
Rush Univ. Cook County Hosp. Chicago Nichd Crs (site Id: 5083)
Chicago, Illinois, United States
Boston Medical Center Ped. Hiv Program Nichd Crs (site Id: 5011)
Boston, Massachusetts, United States
Children'S Hosp. of Boston Nichd Crs (site Id: 5009)
Boston, Massachusetts, United States
Metropolitan Hosp. Nichd Crs (site Id: 5003)
New York, New York, United States
Bronx-Lebanon Hospital Center Nichd Crs (site Id: 5114)
The Bronx, New York, United States
Jacobi Med. Ctr. Bronx Nichd Crs (site Id: 5013)
The Bronx, New York, United States
Dumc Ped. Crs (site Id: 4701)
Durham, North Carolina, United States
Seattle Children'S Research Institute Crs (site Id: 5017)
Seattle, Washington, United States

Zimbabwe

Harare Family Care Crs (site Id: 31890)
Harare, Zimbabwe

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DTG dispersible tabletsDTG film-coated tabletsDTG granules for suspension

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Apr 2011
Primary completion: 20 Jan 2021
Completion: 18 Oct 2023
Last update posted: 12 Dec 2024
Registered enrollment: 181
Registry id: NCT01302847

Cross-registrations

EU-CTR / CTIS (EudraCT)2010-020988-20

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.