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NCT00012519 · ClinicalTrials.gov registry record · Phase 1

Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
29
Enrollment target
12
Study locations

NCT00012519 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 29 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 12 study locations across 8 states.

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The verdict

NCT00012519, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target
12
Study locations

Study Summary

Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.

Conditions Studied

HIV Infections

Interventions

  • DRUG ritonavir
  • DRUG indinavir sulfate

Study Locations (12)

New York

  • Metropolitan Hosp. Ctr. - New York
  • Columbia IMPAACT CRS - New York
  • Harlem Hosp. Ctr. NY NICHD CRS - New York
  • SUNY Upstate Med. Univ., Dept. of Peds. - Syracuse

Florida

  • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy - Gainesville
  • Univ. of Florida Jacksonville NICHD CRS - Jacksonville

District of Columbia

  • Howard Univ. Washington DC NICHD CRS - Washington D.C.

Illinois

  • Chicago Children's CRS - Chicago

Tennessee

  • St. Jude/UTHSC CRS - Memphis

Texas

  • Texas Children's Hosp. CRS - Houston

Virginia

  • VCU Health Systems, Dept. of Peds - Richmond

Other

  • San Juan City Hosp. PR NICHD CRS - San Juan

Trial Details

FieldValue
Enrollment Target 29 participants
Est. Completion 2005-07
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00012519

The ClinicalTrials.gov registry entry for NCT00012519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which ritonavir is the first listed.

NCT00012519 reports 12 study locations spanning 8 distinct geographic areas - top geographies include New York, Florida, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00012519 about?

NCT00012519 is a clinical study titled "Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment". Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well t...

What is the current status of trial NCT00012519?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. Estimated completion is 2005-07.

What conditions does trial NCT00012519 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00012519?

The interventions under investigation include: ritonavir (DRUG), indinavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00012519?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00012519 being conducted?

This trial has 12 study locations across District of Columbia, Florida, Illinois, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.