The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002425
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002425 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
A Multicenter, Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation (Saquinavir SGC) in Combination With Other Antiretroviral Drugs

To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.

All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.

Interventional
Phase 4
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
Drug: Saquinavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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Inclusion Criteria

Concurrent Medication:

Allowed:

Antiretroviral treatments other than PIs.

Patients must have:

  • HIV infection.
  • No prior experience with PIs. (Note:
  • At least 75 percent of patients must be naive to PIs.)

Exclusion Criteria

Concurrent Medication:

Excluded:

PIs other than SQV.

Prior Medication:

Excluded:

Any PIs (see note in General Criteria--Inclusion).

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002425
229E, NV15182B
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
December 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP