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NCT00001091 · ClinicalTrials.gov registry record · Phase 1

Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

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

Completed
Registry status
Phase 1
Development phase
200
Enrollment target
20
Study locations

NCT00001091 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 200 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT00001091, 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
200 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations. Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in doing this.

Conditions Studied

Interventions

  • DRUG Lamivudine
  • DRUG Ritonavir
  • DRUG Stavudine
  • DRUG Nelfinavir mesylate
  • DRUG Nevirapine

Study Locations (20)

California

  • UCSD Med Ctr / Pediatrics / Clinical Sciences - La Jolla
  • Long Beach Memorial (Pediatric) - Long Beach
  • Children's Hosp of Los Angeles/UCLA Med Ctr - Los Angeles
  • Los Angeles County - USC Med Ctr - Los Angeles
  • UCLA Med Ctr / Pediatric - Los Angeles
  • Harbor - UCLA Med Ctr / UCLA School of Medicine - Los Angeles
  • Children's Hosp of Oakland - Oakland
  • UCSF / Moffitt Hosp - Pediatric - San Francisco

Florida

  • North Broward Hosp District - Fort Lauderdale
  • Univ of Florida Gainesville - Gainesville
  • Univ of Florida Health Science Ctr / Pediatrics - Jacksonville
  • Palm Beach County Health Dept - Riviera Beach

District of Columbia

  • Children's Hosp of Washington DC - Washington D.C.
  • Washington Hosp Ctr - Washington D.C.
  • Howard Univ Hosp - Washington D.C.

Connecticut

  • Connecticut Children's Med Ctr - Pediatric - Hartford
  • Yale Univ Med School - New Haven

Georgia

  • Emory Univ Hosp / Pediatrics - Atlanta
  • Med College of Georgia - Augusta

Alabama

  • Univ of Alabama at Birmingham - Pediatric - Birmingham

Trial Details

FieldValue
Enrollment Target 200 participants
Est. Completion 2000-10
Phase Phase 1

What the Registry Record Tells You About NCT00001091

The ClinicalTrials.gov registry entry for NCT00001091 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 200 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 (55% 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 5 interventions - of which Lamivudine is the first listed.

NCT00001091 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00001091 about?

NCT00001091 is a clinical study titled "Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens". The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations. Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in ...

What is the current status of trial NCT00001091?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 200 participants. Estimated completion is 2000-10.

What conditions does trial NCT00001091 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001091?

The interventions under investigation include: Lamivudine (DRUG), Ritonavir (DRUG), Stavudine (DRUG), Nelfinavir mesylate (DRUG), Nevirapine (DRUG).

Who is sponsoring clinical trial NCT00001091?

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 NCT00001091 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. 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.