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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir. At week 8, patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24. Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8, in which case they will be crossed-over to open-label therapy with the alternative drug (i.e., either soft gelatin capsule saquinavir or indinavir).

AS PER AMENDMENT 12/23/96: Viral RNA from weeks 16 and 24 will be assayed in batch after week 24. Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months.

AS PER AMENDMENT 5/7/97: Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy, the study was closed as of March 7, 1997. Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study. Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks. Patients on soft gel capsule saquinavir may switch immediately to indinavir or, when results of HIV RNA and CD4 cell counts are available, may choose to switch to indinavir or remain on soft gel capsule saquinavir. Patients receiving indinavir will continue that agent. Follow-up for all patients will end on 7/4/97.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford CRS
      • San Francisco, California, United States, 94110
        • Ucsf Aids Crs
      • Torrance, California, United States, 90502
        • Harbor-UCLA Med. Ctr. CRS
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital CRS
    • Florida
      • Miami, Florida, United States, 33136
        • Univ. of Miami AIDS CRS
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ACTG CRS
    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • St. Louis ConnectCare, Infectious Diseases Clinic
      • Saint Louis, Missouri, United States, 63110
        • Washington U CRS
    • New York
      • Buffalo, New York, United States, 14260
        • SUNY - Buffalo, Erie County Medical Ctr.
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, United States, 10003
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State Univ. AIDS CRS
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington AIDS CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Required:

  • PCP prophylaxis if CD4 count <= 200 cells/mm3.

Allowed:

  • Intralesional therapy for KS.
  • Vitamins.
  • Nucleoside RT inhibitors, provided regimen remains stable for first 8 weeks of study.

Concurrent Treatment:

Allowed:

  • Acupuncture.
  • Visualization techniques.

Patients must have:

  • HIV infection.
  • Prior hard capsule saquinavir at 1800 mg/day for more than 1 year.

Prior Medication:

Allowed:

  • Prior saquinavir.
  • Prior antiretrovirals, excluding protease inhibitors other than saquinavir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Psychological condition or medical instability that would interfere with study evaluation or procedures.

AS PER AMENDMENT 5/7/97:

  • Active tuberculosis.

Concurrent Medication:

Excluded:

  • Protease inhibitors other than study drugs.
  • Non-nucleoside RT inhibitors.
  • Interferon.
  • Interleukins.
  • GM-CSF.
  • HIV vaccines.
  • Systemic cytotoxic chemotherapy.
  • Investigational drugs other than study medications.
  • Rifabutin.
  • Rifampin.
  • Midazolam.
  • Triazolam.
  • Ketoconazole.
  • Delavirdine.
  • Cisapride.
  • Terfenadine.
  • Astemizole.

AS PER AMENDMENT 5/7/97:

  • Nevirapine.

Patients with the following prior conditions are excluded:

  • Unexplained fever > 38.5 C for any 7 days within 30 days prior to study entry.
  • Diarrhea persisting for 15 days within 30 days prior to study entry.

Prior Medication:

Excluded:

  • Any prior protease inhibitor other than saquinavir.

Excluded within the past 2 months.

  • Change in antiretroviral regimen.
  • Systemic chemotherapy for KS.

Excluded within the past month:

  • Non-nucleoside RT inhibitors.
  • Interferons.
  • Interleukins.
  • HIV vaccines.
  • Experimental therapies.

Excluded within the past 2 weeks:

  • Rifabutin.
  • Cisapride.
  • Terfenadine.
  • Astemizole.
  • Midazolam.
  • Triazolam.
  • Oral ketoconazole.
  • Delavirdine.
  • Acute therapy for infection or other medical illness.

Active substance abuse that would interfere with study evaluation or procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Para MF
  • Study Chair: Collier A
  • Study Chair: Coombs R

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

October 1, 1998

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 333
  • 11305 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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