Overview

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.