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NCT00075907 · ClinicalTrials.gov registry record · Phase 3

Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents

A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
240
Enrollment target
13
Study locations

NCT00075907 is a Phase 3 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 240 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower). The trial reports 13 study locations across 8 states.

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The verdict

NCT00075907, a Phase 3 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
240 participants
Enrollment target
13
Study locations

Study Summary

The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.

Conditions Studied

Interventions

  • DRUG Efavirenz + 2 NRTIs
  • DRUG Lopinavir/Ritonavir + 2 NRTIs
  • PROCEDURE Therapeutic Drug Monitoring

Study Locations (13)

California

  • Usc La Nichd Crs - Alhambra
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp. - Long Beach
  • Children's Hospital of Los Angeles NICHD CRS - Los Angeles

Louisiana

  • Tulane/LSU Maternal/Child CRS - New Orleans
  • Children's Hosp. - New Orleans

New York

  • SUNY Stony Brook NICHD CRS - Stony Brook
  • Bronx-Lebanon Hosp. IMPAACT CRS - The Bronx

Texas

  • Children's Med. Ctr. Dallas - Dallas
  • Texas Children's Hosp. CRS - Houston

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Illinois

  • Chicago Children's CRS - Chicago

Maryland

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases - Baltimore

Tennessee

  • St. Jude/UTHSC CRS - Memphis

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2004-07
Est. Completion 2006-09
Phase Phase 3

What the Registry Record Tells You About NCT00075907

The ClinicalTrials.gov registry entry for NCT00075907 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% 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 3 interventions - of which Efavirenz + 2 NRTIs is the first listed.

NCT00075907 reports 13 study locations spanning 8 distinct geographic areas - top geographies include California, Louisiana, New York.

Frequently Asked Questions

What is clinical trial NCT00075907 about?

NCT00075907 is a clinical study titled "Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents". The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.

What is the current status of trial NCT00075907?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2004-07. Estimated completion is 2006-09.

What conditions does trial NCT00075907 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00075907?

The interventions under investigation include: Efavirenz + 2 NRTIs (DRUG), Lopinavir/Ritonavir + 2 NRTIs (DRUG), Therapeutic Drug Monitoring (PROCEDURE).

Who is sponsoring clinical trial NCT00075907?

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 NCT00075907 being conducted?

This trial has 13 study locations across California, Colorado, Illinois, Louisiana, Maryland. 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.