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

• Status: Completed
• Trial end date: 1998-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Indinavir; Saquinavir

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.