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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect 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.

Gender

ALL

Eligibility 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.