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

Roche

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Saquinavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002383

229M

NV15107

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).