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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.)

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Saquinavir
* Drug: Zalcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saquinavir|nan|
|Drug: Zalcitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors