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NCT00000848 · ClinicalTrials.gov registry record · Phase 2

The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year

A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
144
Enrollment target
16
Study locations

NCT00000848 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 144 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (68% lower). The trial reports 16 study locations across 9 states.

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The verdict

NCT00000848, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
144 participants
Enrollment target
16
Study locations

Study Summary

To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.

Conditions Studied

Interventions

  • DRUG Indinavir sulfate
  • DRUG Saquinavir

Study Locations (16)

New York

  • SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
  • Beth Israel Med. Ctr. (Mt. Sinai) - New York
  • NY Univ. HIV/AIDS CRS - New York
  • Univ. of Rochester ACTG CRS - Rochester

California

  • Stanford CRS - Palo Alto
  • Ucsf Aids Crs - San Francisco
  • Harbor-UCLA Med. Ctr. CRS - Torrance

Illinois

  • Northwestern University CRS - Chicago
  • Rush Univ. Med. Ctr. ACTG CRS - Chicago

Missouri

  • Washington U CRS - St Louis
  • St. Louis ConnectCare, Infectious Diseases Clinic - St Louis

Colorado

  • University of Colorado Hospital CRS - Aurora

Florida

  • Univ. of Miami AIDS CRS - Miami

Massachusetts

  • Massachusetts General Hospital ACTG CRS - Boston

Ohio

  • The Ohio State Univ. AIDS CRS - Columbus

Trial Details

FieldValue
Enrollment Target 144 participants
Est. Completion 1998-10
Phase Phase 2

What the Registry Record Tells You About NCT00000848

The ClinicalTrials.gov registry entry for NCT00000848 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 144 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 (68% 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 Indinavir sulfate is the first listed.

NCT00000848 reports 16 study locations spanning 9 distinct geographic areas - top geographies include New York, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00000848 about?

NCT00000848 is a clinical study titled "The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year". To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with ...

What is the current status of trial NCT00000848?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 144 participants. Estimated completion is 1998-10.

What conditions does trial NCT00000848 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000848?

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

Who is sponsoring clinical trial NCT00000848?

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 NCT00000848 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Illinois, Massachusetts. 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.