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

Conditions: HIV Infections

Summary: to compare the safety, tolerance, and efficacy of saquinavir mesylate (ro 31-8959) alone, zalcitabine (dideoxycytidine; ddc) alone, and both in combination, in patients discontinuing or unable to take zidovudine (azt).

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.)

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.

Keywords: zalcitabine drug therapy, combination acquired immunodeficiency syndrome aids-related complex saquinavir hiv protease inhibitors