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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002333

Run by

Hoffmann-La Roche

People needed

900

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Kaiser Foundation Hosp — Harbor City, California, United States
• UCSD — La Jolla, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• CARE Ctr / UCLA Med Ctr — Los Angeles, California, United States
• UCD — Sacramento, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Davies Med Ctr / c/o HIV Institute — San Francisco, California, United States
• Mount Zion Med Ctr / UCSF — San Francisco, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Pacific Oaks Med Group / Rsch & Scientific Investigation — Sherman Oaks, California, United States
• Sunnyvale Med Clinic — Sunnyvale, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Veterans Administration Med Ctr — Washington D.C., District of Columbia, United States
• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• Univ of Miami Dept of Medicine — Miami, Florida, United States
• Stratogen of South Florida — Miami Beach, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• West Paces Clinical Research Incoporated — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Tulane Univ Med School — New Orleans, Louisiana, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Massachusetts Gen Hosp / Harvard Med School — Boston, Massachusetts, United States
• New England Deaconess Hosp — Boston, Massachusetts, United States
• Harper Hosp — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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