A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 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: NCT00002374
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:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Stavudine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

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


>= 3 months cumulative saquinavir HGC therapy.

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): NCT00002374

United States, California
Pacific Oaks Med Ctr
Beverly Hills, California, United States, 90211
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States, 90048
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
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

Publications: Identifier: NCT00002374     History of Changes
Other Study ID Numbers: 229G
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1997

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

Additional relevant MeSH terms:
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors