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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000848

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

144

Expected to finish

1998-10-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Stanford CRS — Palo Alto, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, 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
• Washington U CRS — St Louis, Missouri, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St 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
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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