Clinical trial NCT00002383: A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Drug Administration Schedule
HIV Protease Inhibitors
Dosage Forms
Saquinavir
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham / 1917 Rsch Cln
state: Alabama
city: San Francisco
country: United States
facility: Davis Med Ctr
state: California
city: San Francisco
country: United States
facility: Mt Zion Hosp of UCSF / HIV Research Ctr
state: California
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group / Research & Scientific Investiga
state: California
city: New Orleans
country: United States
facility: Tulane Univ Med Ctr / Infectious Diseases Sect
state: Louisiana
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: New York
country: United States
facility: Harkness Pavilion
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Galveston
country: United States
facility: Univ of Texas Med Branch / Virology Clinic
state: Texas
Study officials:
References:
citation: Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.