Search / Trial NCT00000848

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Administration, Oral Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Hiv Protease Inhibitors Biological Markers Indinavir Viremia Rna, Viral Saquinavir

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 ...

Gender

ALL

Eligibility criteria

  • 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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Palo Alto, California, United States

San Francisco, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Columbus, Ohio, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0