A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002383
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Harkness Pavilion
🇺🇸New York, New York, United States
Mt Zion Hosp of UCSF / HIV Research Ctr
🇺🇸San Francisco, California, United States
Davis Med Ctr
🇺🇸San Francisco, California, United States
Oregon Health Sciences Univ
🇺🇸Portland, Oregon, United States
Univ of Alabama at Birmingham / 1917 Rsch Cln
🇺🇸Birmingham, Alabama, United States
Pacific Oaks Med Group / Research & Scientific Investiga
🇺🇸Sherman Oaks, California, United States
Kansas City AIDS Research Consortium
🇺🇸Kansas City, Missouri, United States
Univ of Texas Med Branch / Virology Clinic
🇺🇸Galveston, Texas, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Tulane Univ Med Ctr / Infectious Diseases Sect
🇺🇸New Orleans, Louisiana, United States