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A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002374
  Purpose

To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.


Condition Intervention Phase
HIV Infections
Drug: Ritonavir
Drug: Nelfinavir mesylate
Drug: Saquinavir
Drug: Stavudine
Phase III

MedlinePlus related topics:   AIDS    AIDS Medicines   

ChemIDplus related topics:   Stavudine    Nelfinavir    Nelfinavir Mesylate    Ritonavir    Saquinavir    Saquinavir mesylate    Gelatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   120

Detailed Description:

Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 > 100 cells/mm3.
  • Saquinavir HGC-experienced patients (>= 3 months cumulative therapy).

Required:

>= 3 months cumulative saquinavir HGC therapy.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002374

Locations
United States, California
Tower Infectious Diseases / Med Associates Inc    
      Los Angeles, California, United States, 90048
Pacific Oaks Med Ctr    
      Beverly Hills, California, United States, 90211
United States, Florida
Community Research Initiative of South Florida    
      Coral Gables, Florida, United States, 33146
Ctr for Quality Care    
      Tampa, Florida, United States, 33609
United States, Massachusetts
Community Research Initiative of New England    
      Brookline, Massachusetts, United States, 02445
United States, New York
AIDS Ctr    
      New York, New York, United States, 10011
United States, Pennsylvania
Anderson Clinical Research / Inc    
      Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Publications:

Study ID Numbers:   229G, NR15521
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002374
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1  
Drug Therapy, Combination  
Acquired Immunodeficiency Syndrome  
HIV Protease Inhibitors  
RNA, Viral
Saquinavir
Anti-HIV Agents
Viral Load

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Saquinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Nelfinavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on September 05, 2008




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