We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002425
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Primary Purpose: Treatment
HIV Infections
Drug: Saquinavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Not Provided
Not Provided

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).

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002425
229E
NV15182B
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Not Provided
Not Provided
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