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
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors
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.
Sites / Locations
- Kaiser Foundation Hosp
- UCSD
- UCLA School of Medicine
- CARE Ctr / UCLA Med Ctr
- UCD
- UCSF - San Francisco Gen Hosp
- Davies Med Ctr / c/o HIV Institute
- Mount Zion Med Ctr / UCSF
- San Francisco Veterans Administration Med Ctr
- Pacific Oaks Med Group / Rsch & Scientific Investigation
- Sunnyvale Med Clinic
- Harbor - UCLA Med Ctr
- Veterans Administration Med Ctr
- Stratogen of South Florida
- Miami Veterans Administration Med Ctr
- Univ of Miami Dept of Medicine
- AIDS Research Consortium of Atlanta
- West Paces Clinical Research Incoporated
- Rush Presbyterian - Saint Luke's Med Ctr
- Univ of Kansas School of Medicine
- Tulane Univ Med School
- New England Med Ctr
- Massachusetts Gen Hosp / Harvard Med School
- New England Deaconess Hosp
- Harper Hosp
- Washington Univ School of Medicine
- UMDNJ - New Jersey Med School / Cooper Hosp
- UMDNJ - New Jersy Med School
- Albany Med College
- Beth Israel Med Ctr
- Saint Vincent's Hosp and Med Ctr
- Harkness Pavilion
- Ohio State Univ Hosp
- Oregon Health Sciences Univ
- Thomas Jefferson Med College
- Graduate Hosp / Tuttleman Cancer Ctr
- Univ of Tennessee
- Oaklawn Physicians Group
- Univ TX Galveston Med Branch
- Baylor College of Medicine
- Univ of Washington / Harborview Med Ctr
- Southern Alberta HIV Clinic
- McMaster Univ Med Ctr
- Sunnybrook Health Science Ctr
- Clinique Medicale L'Actuele
- Montreal Gen Hosp
- San Juan Veterans Administration Med Ctr