Status:
COMPLETED
The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sa...
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 conducte...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 1998
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00000848
End Date
October 1 1998
Last Update
November 4 2021
Active Locations (16)
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1
Stanford CRS
Palo Alto, California, United States, 94304
2
Ucsf Aids Crs
San Francisco, California, United States, 94110
3
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
4
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045