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
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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).
Condition or disease
Drug: SaquinavirDrug: Zalcitabine
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.)
A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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.
Other antiretroviral drugs.
Nephrotoxic or hepatotoxic drugs.
Drugs likely to cause peripheral neuropathy.
Biologic response modifiers.
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 HIV proteinase inhibitor.
Prior antiretroviral therapy other than AZT.
Acute therapy for opportunistic infection within 14 days prior to study entry.
More than 3 units of blood in any 21-day period within 3 months prior to study entry.