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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000848 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Indinavir sulfate Drug: Saquinavir |
Phase II |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Indinavir Indinavir Sulfate Saquinavir Saquinavir mesylate Gelatin |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 144 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
AS PER AMENDMENT 5/7/97:
Concurrent Medication:
Excluded:
AS PER AMENDMENT 5/7/97:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within the past 2 months.
Excluded within the past month:
Excluded within the past 2 weeks:
Active substance abuse that would interfere with study evaluation or procedures.
United States, California | |||||
Stanford at Kaiser / Kaiser Permanente Med Ctr | |||||
San Francisco, California, United States, 94115 | |||||
San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
Stanford Univ Med Ctr | |||||
Stanford, California, United States, 943055107 | |||||
Children's Hosp of Oakland | |||||
Oakland, California, United States, 946091809 | |||||
United States, Colorado | |||||
Univ of Colorado Health Sciences Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
Rush Presbyterian - Saint Luke's Med Ctr | |||||
Chicago, Illinois, United States, 60612 | |||||
United States, Louisiana | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Massachusetts | |||||
Harvard (Massachusetts Gen Hosp) | |||||
Boston, Massachusetts, United States, 02114 | |||||
United States, Missouri | |||||
St Louis Regional Hosp / St Louis Regional Med Ctr | |||||
St Louis, Missouri, United States, 63112 | |||||
United States, New York | |||||
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr | |||||
New York, New York, United States, 10021 | |||||
Univ of Rochester Medical Center | |||||
Rochester, New York, United States, 14642 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 | |||||
United States, Texas | |||||
Univ of Texas Galveston | |||||
Galveston, Texas, United States, 775550435 | |||||
United States, Washington | |||||
Univ of Washington | |||||
Seattle, Washington, United States, 981224304 |
Study Chair: | Para MF | |
Study Chair: | Collier A | |
Study Chair: | Coombs R |
Click here for more information about Saquinavir 
  |
Click here for more information about Indinavir sulfate 
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Study ID Numbers: | ACTG 333 |
First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000848 |
Health Authority: | United States: Federal Government |
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