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NCT00001133 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir

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

Completed
Registry status
Phase 1
Development phase
50
Enrollment target
7
Study locations

NCT00001133 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 50 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT00001133, 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
50 participants
Enrollment target
7
Study locations

Study Summary

In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look at any side effects that IDV or RTV causes. IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to work against HIV, it must be taken 3 times a day at a high dose and with a certain diet. Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose. This study will gather information about the safety and side effects of using IDV and RTV together.

Conditions Studied

HIV Infections

Interventions

  • DRUG Ritonavir
  • DRUG Indinavir sulfate

Study Locations (7)

California

  • USC CRS - Los Angeles
  • Ucsf Aids Crs - San Francisco

Alabama

  • Alabama Therapeutics CRS - Birmingham

Maryland

  • Johns Hopkins Adult AIDS CRS - Baltimore

New York

  • NY Univ. HIV/AIDS CRS - New York

Ohio

  • Univ. of Cincinnati CRS - Cincinnati

Pennsylvania

  • Pitt CRS - Pittsburgh

Trial Details

FieldValue
Enrollment Target 50 participants
Est. Completion 2006-08
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00001133

The ClinicalTrials.gov registry entry for NCT00001133 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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 (89% 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 2 interventions - of which Ritonavir is the first listed.

NCT00001133 reports 7 study locations spanning 6 distinct geographic areas - top geographies include California, Alabama, Maryland.

Frequently Asked Questions

What is clinical trial NCT00001133 about?

NCT00001133 is a clinical study titled "Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir". In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look ...

What is the current status of trial NCT00001133?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. Estimated completion is 2006-08.

What conditions does trial NCT00001133 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001133?

The interventions under investigation include: Ritonavir (DRUG), Indinavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00001133?

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 NCT00001133 being conducted?

This trial has 7 study locations across Alabama, California, Maryland, New York, Ohio. 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.