A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • G-CSF and erythropoietin.
• • Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.
• Concurrent Treatment:
• Allowed:
• • Limited localized radiation therapy to the skin.
• Patients must have:
• • Documented HIV infection.
• • CD4 count 50 - 300 cells/mm3.
• • Received prior AZT that has been discontinued at least 28 days prior to study entry.
• • No active opportunistic infection requiring immediate treatment.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Signs or symptoms of peripheral neuropathy.
• • Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.
• • Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.
• • Any grade 3 or worse laboratory or clinical abnormality.
• • Inability to comply with protocol requirements.
• Concurrent Medication:
• Excluded:
• • Other antiretroviral drugs.
• • Experimental drugs.
• • Nephrotoxic or hepatotoxic drugs.
• • Drugs likely to cause peripheral neuropathy.
• • Antineoplastic agents.
• • Biologic response modifiers.
• Concurrent Treatment:
• Excluded:
• • Radiation therapy other than limited localized therapy to skin.
• Patients with the following prior conditions are excluded:
• • History of non-Hodgkin's lymphoma.
• • Unexplained fever \>= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.
• • Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.
• • History of grade 2 or worse peripheral neuropathy.
• Prior Medication:
• Excluded:
• • Prior HIV proteinase inhibitor.
• • Prior antiretroviral therapy other than AZT.
• • Acute therapy for opportunistic infection within 14 days prior to study entry.
• Prior Treatment:
• Excluded:
• • More than 3 units of blood in any 21-day period within 3 months prior to study entry.
• Required:
• • Prior AZT.