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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 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.

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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.

Interventions

  • DRUG Ritonavir
  • DRUG ATV

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2000-11
Est. Completion 2014-09
Phase Phase 1

What the Registry Record Tells You About NCT00006604

The ClinicalTrials.gov registry entry for NCT00006604 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ritonavir is the first listed.

NCT00006604 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.