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

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. According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00075907 record still lists

NCT00075907 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower).

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 lists 13 locations in 8 states (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.

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00075907's enrollment target sits among peer trials

240 150th of 542 higher than 391 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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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Source: ClinicalTrials.gov NCT00075907, the US trial registry maintained by the National Library of Medicine. NCT00075907 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.