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NCT00001119 · ClinicalTrials.gov registry record · NA

Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

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

Completed
Registry status
NA
Development phase
288
Enrollment target
12
Study locations

NCT00001119 is a NA study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 288 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (35% lower). The trial reports 12 study locations across 9 states.

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The verdict

NCT00001119, a NA study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
288 participants
Enrollment target
12
Study locations

Study Summary

The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to HIV and anti-HIV drugs. Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV drugs taken by patients who have had HIV for a long time. These drugs lower the level of HIV in the blood. However, doctors do not know whether patients who take anti-HIV drugs in the early stages of HIV infection actually live longer or have fewer AIDS-related diseases. This study will help doctors answer these questions. In the main study, doctors will look at how 2 different anti-HIV drug combinations affect the immune system. In the 2 substudies, doctors will look at how the body reacts to the hepatitis B vaccine and the tetanus vaccine. These substudies may help doctors learn how HIV-infected patients respond to new infections.

Conditions Studied

HIV Infections

Interventions

  • DRUG Ritonavir
  • DRUG Indinavir sulfate
  • DRUG Lamivudine/Zidovudine
  • DRUG Abacavir sulfate
  • BIOLOGICAL Tetanus Toxoid Vaccine

Study Locations (12)

Washington

  • Seattle HIVNET - Seattle
  • Univ of Washington - Seattle
  • Fred Hutchinson Cancer Research Ctr - Seattle

New York

  • New York Univ Med Ctr - New York
  • Bronx-Lebanon Hosp Ctr - The Bronx

California

  • San Francisco Dept of Hlth / AIDS Office - San Francisco

Illinois

  • Univ of Illinois Chicago / Howard Brown Hlth Ctr - Chicago

Massachusetts

  • Fenway Community Health Ctr / HIVNET - Boston

Minnesota

  • Univ of Minnesota - Minneapolis

Ohio

  • Univ of Cincinnati - Cincinnati

Rhode Island

  • Mem Hosp of Rhode Island - Pawtucket

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 1999-10
Phase NA

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00001119

The ClinicalTrials.gov registry entry for NCT00001119 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 288 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 (35% 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 Ritonavir is the first listed.

NCT00001119 reports 12 study locations spanning 9 distinct geographic areas - top geographies include Washington, New York, California.

Frequently Asked Questions

What is clinical trial NCT00001119 about?

NCT00001119 is a clinical study titled "Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV". The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to HIV and anti-HIV drugs. Doctors generally treat patients in the early ...

What is the current status of trial NCT00001119?

This trial is currently completed. It is a NA study. The enrollment target is 288 participants. The study started on 1999-10.

What conditions does trial NCT00001119 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001119?

The interventions under investigation include: Ritonavir (DRUG), Indinavir sulfate (DRUG), Lamivudine/Zidovudine (DRUG), Abacavir sulfate (DRUG), Tetanus Toxoid Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00001119?

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 NCT00001119 being conducted?

This trial has 12 study locations across California, Illinois, Massachusetts, Minnesota, New York. 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.