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

Inclusion 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.