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A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002162
  Purpose

To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Zalcitabine
Drug: Didanosine
Phase II

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Zidovudine    Lamivudine    Didanosine    Stavudine    Zalcitabine    Saquinavir    Saquinavir mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

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

Estimated Enrollment:   140

Detailed Description:

Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • HIV infection.
  • Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.
  • No more than 2 weeks of prior treatment with a protease inhibitor.
  • No active opportunistic infection or other serious AIDS-defining condition.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malabsorption or inadequate oral intake.
  • Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).
  • Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.
  • Active malignancy or anticipated need for chemotherapy during the study.
  • Anticipated need for disallowed medications during the study.

Concurrent Medication:

Excluded:

  • Other protease inhibitors.

Prior Medication:

Excluded:

  • More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen.
  • More than 2 weeks of any protease inhibitor.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002162

Show 27 study locations  Show 27 Study Locations

Sponsors and Collaborators
Hoffmann-La Roche
  More Information


Publications:

Study ID Numbers:   229D, NV15355
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002162
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Antiviral Agents  
Saquinavir  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Stavudine
Saquinavir
Acquired Immunodeficiency Syndrome
Zalcitabine
Zidovudine
Lamivudine
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on September 16, 2008




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