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

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00000848
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
144
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

Stanford CRS

🇺🇸

Palo Alto, California, United States

Ucsf Aids Crs

🇺🇸

San Francisco, California, United States

University of Colorado Hospital CRS

🇺🇸

Aurora, Colorado, United States

Washington U CRS

🇺🇸

Saint Louis, Missouri, United States

St. Louis ConnectCare, Infectious Diseases Clinic

🇺🇸

Saint Louis, Missouri, United States

SUNY - Buffalo, Erie County Medical Ctr.

🇺🇸

Buffalo, New York, United States

Beth Israel Med. Ctr. (Mt. Sinai)

🇺🇸

New York, New York, United States

NY Univ. HIV/AIDS CRS

🇺🇸

New York, New York, United States

Univ. of Rochester ACTG CRS

🇺🇸

Rochester, New York, United States

Harbor-UCLA Med. Ctr. CRS

🇺🇸

Torrance, California, United States

Univ. of Miami AIDS CRS

🇺🇸

Miami, Florida, United States

Northwestern University CRS

🇺🇸

Chicago, Illinois, United States

Rush Univ. Med. Ctr. ACTG CRS

🇺🇸

Chicago, Illinois, United States

Massachusetts General Hospital ACTG CRS

🇺🇸

Boston, Massachusetts, United States

The Ohio State Univ. AIDS CRS

🇺🇸

Columbus, Ohio, United States

University of Washington AIDS CRS

🇺🇸

Seattle, Washington, United States

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