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NCT00005762 · ClinicalTrials.gov registry record · NA

Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers

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

Completed
Registry status
NA
Development phase
90
Enrollment target
8
Study locations

NCT00005762 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 90 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT00005762, a NA study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
90 participants
Enrollment target
8
Study locations

Study Summary

The purpose of this study is to measure the blood levels of amprenavir (APV) alone, APV combined with efavirenz (EFV), and APV/EFV combined with a third drug (nelfinavir \[NFV\], indinavir \[IDV\], ritonavir soft gel capsules \[RTV sgc\], or saquinavir soft gel capsules \[SQV sgc\]). Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV infections. Doctors need to know the best dosages of certain drugs when they are given in combination. This study will measure the blood levels of APV alone, APV combined with EFV, and APV/EFV plus a second PI in healthy volunteers. It will study the safety and tolerance of these drugs.

Conditions Studied

Interventions

  • DRUG Ritonavir
  • DRUG Efavirenz
  • DRUG Indinavir sulfate
  • DRUG Nelfinavir mesylate
  • DRUG Amprenavir

Study Locations (8)

California

  • Stanford CRS - Palo Alto

Colorado

  • University of Colorado Hospital CRS - Aurora

Hawaii

  • Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis

Maryland

  • Johns Hopkins Adult AIDS CRS - Baltimore

Ohio

  • The Ohio State University Medical Center - Columbus

Tennessee

  • Vanderbilt Univ. Med. Ctr., AIDS Clinical Trials Ctr. - Nashville

Washington

  • University of Washington AIDS CRS - Seattle

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2001-03
Est. Completion 2004-05
Phase NA

What the Registry Record Tells You About NCT00005762

The ClinicalTrials.gov registry entry for NCT00005762 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 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 (80% 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.

NCT00005762 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Colorado, Hawaii.

Frequently Asked Questions

What is clinical trial NCT00005762 about?

NCT00005762 is a clinical study titled "Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers". The purpose of this study is to measure the blood levels of amprenavir (APV) alone, APV combined with efavirenz (EFV), and APV/EFV combined with a third drug (nelfinavir \[NFV\], indinavir \[IDV\], ritonavir soft gel capsules \[RTV sgc\], or saquinavir soft gel capsules \[SQV sgc\]). Anti-HIV thera...

What is the current status of trial NCT00005762?

This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2001-03. Estimated completion is 2004-05.

What conditions does trial NCT00005762 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00005762?

The interventions under investigation include: Ritonavir (DRUG), Efavirenz (DRUG), Indinavir sulfate (DRUG), Nelfinavir mesylate (DRUG), Amprenavir (DRUG).

Who is sponsoring clinical trial NCT00005762?

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 NCT00005762 being conducted?

This trial has 8 study locations across California, Colorado, Hawaii, Indiana, 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.