Clinical trialNCT00485264CompletedPhase 1/PHASE2Interventional

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment153HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected 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, MD
Jacobi Medical Center, Albert Einstein College of Medicine
Study Chair
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Sharon A. Nachman, MD
State University of New York at Stony Brook, Health Science Center
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

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

Argentina

Hosp. General de Agudos Buenos Aires Argentina Nichd Crs
Ciudad de Buenos Aires, Buenos Aires, Argentina

Botswana

Gaborone Crs
Gaborone, Botswana

Brazil

Som Federal University Minas Gerais Brazil Nichd Crs
Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora Da Conceicao Nichd Crs
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Federal Dos Servidores Do Estado Nichd Crs
Rio de Janeiro, Brazil
Instituto de Puericultura E Pediatria Martagao Gesteira - Ufrj Nichd Crs
Rio de Janeiro, Brazil
Inst de Infectologia Emilio Ribas Sao Paulo Brazil Nichd Crs
São Paulo, Brazil
Univ. of Sao Paulo Brazil Nichd Crs
São Paulo, Brazil

Puerto Rico

San Juan City Hosp. Pr Nichd Crs
San Juan, Puerto Rico

South Africa

Shandukani Research Crs
Johannesburg, Gauteng, South Africa
Soweto Impaact Crs
Johannesburg, Gauteng, South Africa
Durban Paediatric Hiv Crs
Durban, KwaZulu-Natal, South Africa
Family Clinical Research Unit (fam-Cru) Crs
Tygerberg, Western Cape, South Africa

United States

Usc la Nichd Crs
Alhambra, California, United States
University of California, Uc San Diego Crs
La Jolla, California, United States
Children'S Hospital of Los Angeles Nichd Crs
Los Angeles, California, United States
David Geffen School of Medicine at Ucla Nichd Crs
Los Angeles, California, United States
Univ. of California San Francisco Nichd Crs
San Francisco, California, United States
Univ. of Colorado Denver Nichd Crs
Aurora, Colorado, United States
Children'S National Med. Ctr. Washington Dc Nichd Crs
Washington D.C., District of Columbia, United States
Howard Univ. Washington Dc Nichd Crs
Washington D.C., District of Columbia, United States
South Florida Cdtc Ft Lauderdale Nichd Crs
Fort Lauderdale, Florida, United States
Univ. of Florida Jacksonville Nichd Crs
Jacksonville, Florida, United States
Usf - Tampa Nichd Crs
Tampa, Florida, United States
Ann & Robert H. Lurie Children'S Hospital of Chicago (lch) Crs
Chicago, Illinois, United States
Rush Univ. Cook County Hosp. Chicago Nichd Crs
Chicago, Illinois, United States
Tulane Univ. New Orleans Nichd Crs
New Orleans, Louisiana, United States
Johns Hopkins Univ. Baltimore Nichd Crs
Baltimore, Maryland, United States
Boston Medical Center Ped. Hiv Program Nichd Crs
Boston, Massachusetts, United States
Children'S Hosp. of Boston Nichd Crs
Boston, Massachusetts, United States
Wne Maternal Pediatric Adolescent Aids Crs
Worcester, Massachusetts, United States
Columbia Impaact Crs
New York, New York, United States
Metropolitan Hosp. Nichd Crs
New York, New York, United States
Nyu Ny Nichd Crs
New York, New York, United States
Suny Stony Brook Nichd Crs
Stony Brook, New York, United States
Bronx-Lebanon Hospital Center Nichd Crs
The Bronx, New York, United States
Jacobi Med. Ctr. Bronx Nichd Crs
The Bronx, New York, United States
Dumc Ped. Crs
Durham, North Carolina, United States
Philadelphia Impaact Unit Crs
Philadelphia, Pennsylvania, United States
St. Jude Children'S Research Hospital Crs
Memphis, Tennessee, United States

2 more sites on the registry record.ClinicalTrials.gov ↗

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.

Raltegravir →Raltegravir oral granules for suspensionRaltegravir poloxamer film coated tablet

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: 17 Sept 2007
Primary completion: 3 Jun 2013
Completion: 18 May 2017
Last update posted: 2 Nov 2021
Registered enrollment: 153
Registry id: NCT00485264

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.