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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002162
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002162 on ClinicalTrials.gov Archive Site
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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
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

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

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Saquinavir
  • Drug: Lamivudine
  • Drug: Stavudine
  • Drug: Zidovudine
  • Drug: Zalcitabine
  • Drug: Didanosine
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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
140
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002162
229D, NV15355
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
August 1997

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