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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

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. Identifier: NCT00002229
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Saquinavir Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002229

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Sponsors and Collaborators
Hoffmann-La Roche
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Study Chair: S Palleja
Study Chair: C Karol
Layout table for additonal information Identifier: NCT00002229    
Other Study ID Numbers: 229Q
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 1999
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors