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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002383

Run by

Hoffmann-La Roche

People needed

80

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• Univ of Alabama at Birmingham / 1917 Rsch Cln — Birmingham, Alabama, 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, United States
• Tulane Univ Med Ctr / Infectious Diseases Sect — New Orleans, Louisiana, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Kansas City AIDS Research Consortium — Kansas City, Missouri, United States
• Harkness Pavilion — New York, New York, United States
• Oregon Health Sciences Univ — Portland, Oregon, United States
• Univ of Texas Med Branch / Virology Clinic — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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