The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
- Conditions
- HIV Infections
- Registration Number
- NCT00000848
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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