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
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
3 other identifiers
interventional
900
3 countries
47
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1995
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Kaiser Foundation Hosp
Harbor City, California, 90710, United States
UCSD
La Jolla, California, 920930679, United States
UCLA School of Medicine
Los Angeles, California, 900121973, United States
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095, United States
UCD
Sacramento, California, 95817, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, 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
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 D.C., District of Columbia, 20422, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Univ of Miami Dept of Medicine
Miami, Florida, 33136, United States
Stratogen of South Florida
Miami Beach, Florida, 33140, 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
New England Med Ctr
Boston, Massachusetts, 02111, United States
Massachusetts Gen Hosp / Harvard Med School
Boston, Massachusetts, 02114, United States
New England Deaconess Hosp
Boston, Massachusetts, 02215, 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
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Harkness Pavilion
New York, New York, 10032, United States
Ohio State Univ Hosp
Columbus, Ohio, 43210, United States
Oregon Health Sciences Univ
Portland, Oregon, 97201, United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107, United States
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, 19146, United States
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
Southern Alberta HIV Clinic
Calgary, Alberta, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico
Related Publications (1)
Revicki D, Swartz C. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir-zalcitabine therapy for advanced HIV-infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:113 (abstract no 266)
BACKGROUND