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).
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.
San Juan Veterans Administration Med Ctr, San Juan 009275800, Puerto Rico
Southern Alberta HIV Clinic, Calgary, Alberta, Canada
Kaiser Foundation Hosp, Harbor City, California 90710, United States
UCSD, La Jolla, California 920930679, United States
CARE Ctr / UCLA Med Ctr, Los Angeles, California 90095, United States
UCLA School of Medicine, Los Angeles, California 900121973, United States
UCD, Sacramento, California 95817, United States
Davies Med Ctr / c/o HIV Institute, San Francisco, California 94114, United States
Mount Zion Med Ctr / UCSF, San Francisco, California 94115, United States
San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States
UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States
Pacific Oaks Med Group / Rsch & Scientific Investigation, Sherman Oaks, California 91403, United States
Sunnyvale Med Clinic, Sunnyvale, California 94086, United States
Harbor - UCLA Med Ctr, Torrance, California 90505, United States
Veterans Administration Med Ctr, Washington, District of Columbia 20422, United States
Stratogen of South Florida, Miami Beach, Florida 33140, United States
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
Univ of Miami Dept of Medicine, Miami, Florida 33136, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
West Paces Clinical Research Incoporated, Atlanta, Georgia 30327, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States
Tulane Univ Med School, New Orleans, Louisiana 70112, United States
Massachusetts Gen Hosp / Harvard Med School, Boston, Massachusetts 02114, United States
New England Deaconess Hosp, Boston, Massachusetts 02215, United States
New England Med Ctr, Boston, Massachusetts 02111, United States
Harper Hosp, Detroit, Michigan 48201, United States
Washington Univ School of Medicine, St. Louis, Missouri 63108, United States
UMDNJ - New Jersey Med School / Cooper Hosp, Camden, New Jersey 08103, United States
UMDNJ - New Jersy Med School, Newark, New Jersey 08103, United States
Albany Med College, Albany, New York 12208, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Harkness Pavilion, New York, New York 10032, United States
Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States
Ohio State Univ Hosp, Columbus, Ohio 43210, United States
McMaster Univ Med Ctr, Hamilton, Ontario, Canada
Sunnybrook Health Science Ctr, Toronto, Ontario, Canada
Oregon Health Sciences Univ, Portland, Oregon 97201, United States
Graduate Hosp / Tuttleman Cancer Ctr, Philadelphia, Pennsylvania 19146, United States
Thomas Jefferson Med College, Philadelphia, Pennsylvania 19107, United States
Clinique Medicale L'Actuele, Montreal, Quebec, Canada
Montreal Gen Hosp, Montreal, Quebec, Canada
Univ of Tennessee, Memphis, Tennessee 38163, United States
Oaklawn Physicians Group, Dallas, Texas 75219, United States
Univ TX Galveston Med Branch, Galveston, Texas 775550882, United States
Baylor College of Medicine, Houston, Texas 77005, United States
Univ of Washington / Harborview Med Ctr, Seattle, Washington 98104, United States
Revicki DA, Swartz C, Wu AW, Haubrich R, Collier AC. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir plus zalcitabine therapy for adults with advanced HIV infection with CD4 counts between 50 and 300 cells/mm3. Antivir Ther. 1999;4(1):35-44.
