Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Public ClinicalTrials.gov record NCT00006604. 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
Phase I/II, Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS 232632, Atazanavir, ATV, Reyataz) in Combination Regimens in Antiretroviral Therapy (ART)-Naive and -Experienced HIV-Infected Infants, Children, and Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
Study identification
- NCT ID
- NCT00006604
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 195 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 91 Days to 21 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
- Oct 31, 2000
- Primary completion
- Sep 30, 2011
- Completion
- Aug 31, 2014
- Last update posted
- Nov 4, 2021
2000 – 2014
United States locations
- U.S. sites
- 32
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Pediatric Infectious Diseases CRS | Birmingham | Alabama | 35233 | — |
| Usc La Nichd Crs | Alhambra | California | 91803 | — |
| University of California, UC San Diego CRS | La Jolla | California | 92093-0672 | — |
| Miller Children's Hosp. Long Beach CA NICHD CRS | Long Beach | California | 90806 | — |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | 900951752 | — |
| Univ. of California San Francisco NICHD CRS | San Francisco | California | 94143 | — |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 80045 | — |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | — |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | — |
| Columbus Regional HealthCare System, The Med. Ctr. | Columbus | Georgia | 31901 | — |
| 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 | — |
| Tulane Univ. New Orleans NICHD CRS | New Orleans | Louisiana | 701122699 | — |
| Univ. of Maryland Baltimore NICHD CRS | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | — |
| Boston Medical Center Ped. HIV Program NICHD CRS | Boston | Massachusetts | 02118 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 016550001 | — |
| Rutgers - New Jersey Medical School CRS | Newark | New Jersey | 07103 | — |
| Nyu Ny Nichd Crs | New York | New York | 10016 | — |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | — |
| 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 | 277103499 | — |
| Philadelphia IMPAACT Unit CRS | Philadelphia | Pennsylvania | 19104 | — |
| St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | 191341095 | — |
| St. Jude Children's Research Hospital CRS | Memphis | Tennessee | 38105 | — |
| Children's Med. Ctr. Dallas | Dallas | Texas | 75235 | — |
| Texas Children's Hospital CRS | Houston | Texas | 77030 | — |
| Children's Hosp. of the King's Daughters, Infectious Disease | Norfolk | Virginia | 23507 | — |
| Childrens Hosp. of the Kings Daughters | Norfolk | Virginia | 23507 | — |
| 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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00006604, 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 4, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00006604 live on ClinicalTrials.gov.