A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

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

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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.