Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
Public ClinicalTrials.gov record NCT00006325. 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
Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
Study identification
- NCT ID
- NCT00006325
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 16 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
- Not listed
- Primary completion
- Not listed
- Completion
- Feb 29, 2004
- Last update posted
- Oct 31, 2021
Ends 2004
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial (Pediatric) | Long Beach | California | 90801 | — |
| Children's Hosp of Los Angeles/UCLA Med Ctr | Los Angeles | California | 900276016 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| UCSF / Moffitt Hosp - Pediatric | San Francisco | California | 941430105 | — |
| Connecticut Children's Med Ctr | Farmington | Connecticut | 060303805 | — |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | — |
| Univ of Massachusetts Med School | Worcester | Massachusetts | 016550001 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Schneider Children's Hosp | New Hyde Park | New York | 11040 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Texas Children's Hosp / Baylor Univ | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00006325, 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 Oct 31, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00006325 live on ClinicalTrials.gov.