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Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002229
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
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No Changes Posted
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Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men
The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.
Interventional
Phase 4
Masking: None (Open Label)
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
80
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Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have an HIV count of 5,000 copies/ml or more.
  • Have a CD4 count of 100 cells/mm3 or more.
  • Meet specific requirements if you have ever taken NRTIs.
  • Are 16 - 64 years old (need consent if under 18).
  • Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
  • Have taken all the available NRTIs.
  • Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
  • Have a history of weight loss, muscle pain, and loss of appetite.
  • Have taken certain medications, including anti-HIV drugs other than those required by this study.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.
  • Are unable to complete the study for any reason.
Sexes Eligible for Study: All
16 Years to 64 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   United States
 
 
NCT00002229
229Q
NR15750
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Hoffmann-La Roche
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Study Chair: S Palleja
Study Chair: C Karol
NIH AIDS Clinical Trials Information Service
December 1999

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