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A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002383
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002383 on ClinicalTrials.gov Archive Site
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A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
A Randomized, Parallel, Open-Label Study Comparing Saquinavir (Hard Gelatin Formulation, 600 Mg Tid) to Saquinavir Soft Gelatin Formulation [(400 Mg, 800 Mg, 1200 Mg) Tid} x 4 Weeks in HIV Infected Patients

To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.

Patients are randomly assigned to one of the four treatment groups as follows:

Group 1: 10 patients receive saquinavir HGC. Group 2: 10 patients receive saquinavir SGC. Group 3: 30 patients receive saquinavir SGC at an intermediate dose. Group 4: 30 patients receive saquinavir SGC at the highest study dose. Upon completion of the initial 4 weeks, all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes. If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC, patients may have the option to change to this optimal dose in a treatment extension phase of the protocol. Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity, their CD4 count or HIV-RNA levels return to baseline, until saquinavir is approved by the FDA or study termination, whichever comes first.

NOTE: A washout >= 28 days is required for patients on antiretroviral therapy.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: Saquinavir
Not Provided
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
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Inclusion Criteria

Patients must have:

  • CD4 count of 100 to 500 cells/mm3.
  • Greater than 20,000 HIV-RNA copies/ml.

Exclusion Criteria

Prior Medication:

Excluded:

Prior treatment with protease inhibitors.

Required:

  • Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).
  • At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002383
229M, NV15107
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
July 1997

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