Sherman Oaks,
California
91403
Purpose:
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of
saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro
31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different
regimens.
Study summary:
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT
plus Ro 31-8959, or all three drugs.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Erythropoietin and G-CSF.
Concurrent Treatment:
Allowed:
- Local skin radiotherapy.
Patients must have:
- HIV infection.
- CD4 count 50 - 350 cells/mm3.
- No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
- No acute serious opportunistic infections requiring immediate treatment.
- No unexplained fever persisting for 14 days within 90 days prior to study entry.
- No significant unexplained diarrhea persisting for 14 days within 30 days prior to
study entry.
- No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or
radiotherapy.
- Life expectancy of at least 80 weeks.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Malabsorption.
- Severe chronic diarrhea.
- Inadequate oral intake (unable to eat one or more meals daily because of chronic
nausea, emesis, or abdominal/oral-esophageal discomfort).
- Any grade 3 or worse toxicity.
- Inability to comply with study requirements.
Concurrent Medication:
Excluded:
- Other investigational agents.
- Antineoplastic agents.
- Biologic response modifiers (including interferons).
- Foscarnet.
- Anti-HIV drugs other than the study drugs.
Concurrent Treatment:
Excluded:
- Radiotherapy (other than local skin radiotherapy).
Patients with the following prior condition are excluded:
History of non-Hodgkin's lymphoma.
Prior Medication:
Excluded:
- Acute therapy for opportunistic infection within 14 days prior to study entry.
- Prior HIV proteinase inhibitor.