A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Didanosine; Lamivudine; Saquinavir; Stavudine; Zalcitabine; Zidovudine

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.

• Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.

• No more than 2 weeks of prior treatment with a protease inhibitor.

• No active opportunistic infection or other serious AIDS-defining condition.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malabsorption or inadequate oral intake.

• Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).

• Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.

• Active malignancy or anticipated need for chemotherapy during the study.

• Anticipated need for disallowed medications during the study.

Concurrent Medication:

Excluded:

• Other protease inhibitors.

Prior Medication:

Excluded:

• More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen.

• More than 2 weeks of any protease inhibitor.