Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Public ClinicalTrials.gov record NCT00485264. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Raltegravir (Isentress, MK-0518) in HIV-1 Infected Children and Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00485264
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- Raltegravir poloxamer film coated tablet Drug
- Raltegravir chewable tablet Drug
- Raltegravir oral granules for suspension (20 mg/mL) Drug
Drug
Eligibility (public fields only)
- Age range
- 30 Days to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2007 (Actual)
- Primary completion
- Jun 3, 2013 (Actual)
- Completion
- May 18, 2017 (Actual)
- Last update posted
- Nov 2, 2021
2007 – 2017
United States locations
- U.S. sites
- 29
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Usc La Nichd Crs | Alhambra | California | 91803 | — |
| University of California, UC San Diego CRS | La Jolla | California | 92093-0672 | — |
| Children's Hospital of Los Angeles NICHD CRS | Los Angeles | California | 90027-6062 | — |
| David Geffen School of Medicine at UCLA NICHD CRS | Los Angeles | California | 90095-1752 | — |
| Univ. of California San Francisco NICHD CRS | San Francisco | California | 94143 | — |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 80045 | — |
| Children's National Med. Ctr. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20010 | — |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | — |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| USF - Tampa NICHD CRS | Tampa | Florida | 33606 | — |
| Rush Univ. Cook County Hosp. Chicago NICHD CRS | Chicago | Illinois | 60612 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS | Chicago | Illinois | 60614-3393 | — |
| Tulane Univ. New Orleans NICHD CRS | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | — |
| Children's Hosp. of Boston NICHD CRS | Boston | Massachusetts | 02115 | — |
| Boston Medical Center Ped. HIV Program NICHD CRS | Boston | Massachusetts | 02118 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 01605 | — |
| Nyu Ny Nichd Crs | New York | New York | 10016 | — |
| Metropolitan Hosp. NICHD CRS | New York | New York | 10029 | — |
| Columbia IMPAACT CRS | New York | New York | 10032 | — |
| SUNY Stony Brook NICHD CRS | Stony Brook | New York | 11794-8111 | — |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | — |
| Jacobi Med. Ctr. Bronx NICHD CRS | The Bronx | New York | 10461 | — |
| DUMC Ped. CRS | Durham | North Carolina | 27710 | — |
| Philadelphia IMPAACT Unit CRS | Philadelphia | Pennsylvania | 19104 | — |
| St. Jude Children's Research Hospital CRS | Memphis | Tennessee | 38105-3678 | — |
| Texas Children's Hospital CRS | Houston | Texas | 77030-2399 | — |
| Seattle Children's Research Institute CRS | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00485264, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2021 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00485264 live on ClinicalTrials.gov.