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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002383
• Other study ID #: 229M
• Secondary ID: NV15107
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Saquinavir

Locations

Country	Name	City	State
United States	Univ of Alabama at Birmingham / 1917 Rsch Cln	Birmingham	Alabama
United States	New England Med Ctr	Boston	Massachusetts
United States	Univ of Texas Med Branch / Virology Clinic	Galveston	Texas
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Tulane Univ Med Ctr / Infectious Diseases Sect	New Orleans	Louisiana
United States	Harkness Pavilion	New York	New York
United States	Oregon Health Sciences Univ	Portland	Oregon
United States	Davis Med Ctr	San Francisco	California
United States	Mt Zion Hosp of UCSF / HIV Research Ctr	San Francisco	California
United States	Pacific Oaks Med Group / Research & Scientific Investiga	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. — View Citation