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

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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).

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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