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NCT00006604 · ClinicalTrials.gov registry record · Phase 1
Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 195
- Enrollment target
NCT00006604: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00006604 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 195 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (225% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006604, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 195 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Total Bilirubin \>= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team.
Interventions
- DRUG Ritonavir
- DRUG ATV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2000-11 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT00006604 record still lists
NCT00006604 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (225% higher).
The record links to 0 conditions, and to 2 interventions - of which Ritonavir is the first listed.
NCT00006604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006604 about?
NCT00006604 is a clinical study titled "Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents". 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 HI...
What is the current status of trial NCT00006604?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 195 participants. The study started on 2000-11. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00006604?
The interventions under investigation include: Ritonavir (DRUG), ATV (DRUG).
Who is sponsoring clinical trial NCT00006604?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00006604's enrollment target sits among peer trials
195 281st of 2000 higher than 1,719 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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