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Home > "A" Clinical Trials Conditions > 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 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 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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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).
Details: Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 900

Location and Contact Information:

UCSF - San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

Montreal Gen Hosp
Montreal,  Quebec, 
Canada
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Clinique Medicale L'Actuele
Montreal,  Quebec, 
Canada
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

San Francisco Veterans Administration Med Ctr
San Francisco,  California,  94121
United States
 

Washington Univ School of Medicine
St. Louis,  Missouri,  63108
United States
 

McMaster Univ Med Ctr
Hamilton,  Ontario, 
Canada
 

Albany Med College
Albany,  New York,  12208
United States
 

Miami Veterans Administration Med Ctr
Miami,  Florida,  33125
United States
 

Univ of Washington / Harborview Med Ctr
Seattle,  Washington,  98104
United States
 

Davies Med Ctr / c/o HIV Institute
San Francisco,  California,  94114
United States
 

Sunnyvale Med Clinic
Sunnyvale,  California,  94086
United States
 

Ohio State Univ Hosp
Columbus,  Ohio,  43210
United States
 

Massachusetts Gen Hosp / Harvard Med School
Boston,  Massachusetts,  02114
United States
 

Harkness Pavilion
New York City,  New York,  10032
United States
 

Southern Alberta HIV Clinic
Calgary,  Alberta, 
Canada
 

Univ of Tennessee
Memphis,  Tennessee,  38163
United States
 

CARE Ctr / UCLA Med Ctr
Los Angeles,  California,  90095
United States
 

Univ TX Galveston Med Branch
Galveston,  Texas,  775550882
United States
 

UCD
Sacramento,  California,  95817
United States
 

Thomas Jefferson Med College
Philadelphia,  Pennsylvania,  19107
United States
 

Harbor - UCLA Med Ctr
Torrance,  California,  90505
United States
 

Oregon Health Sciences Univ
Portland,  Oregon,  97201
United States
 

Tulane Univ Med School
New Orleans,  Louisiana,  70112
United States
 

Univ of Miami Dept of Medicine
Miami,  Florida,  33136
United States
 

Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia,  Pennsylvania,  19146
United States
 

Mount Zion Med Ctr / UCSF
San Francisco,  California,  94115
United States
 

Baylor College of Medicine
Houston,  Texas,  77005
United States
 

Stratogen of South Florida
Miami,  Florida,  33140
United States
 

Kaiser Foundation Hosp
Harbor City,  California,  90710
United States
 

New England Deaconess Hosp
Boston,  Massachusetts,  02215
United States
 

Univ of Kansas School of Medicine
Wichita,  Kansas,  67214
United States
 

Pacific Oaks Med Group / Rsch & Scientific Investigation
Sherman Oaks,  California,  91403
United States
 

Harper Hosp
Detroit,  Michigan,  48201
United States
 

Sunnybrook Health Science Ctr
Toronto,  Ontario, 
Canada
 

Oaklawn Physicians Group
Dallas,  Texas,  75219
United States
 

New England Med Ctr
Boston,  Massachusetts,  02111
United States
 

UMDNJ - New Jersy Med School
Newark,  New Jersey,  08103
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

UCSD
La Jolla,  California,  920930679
United States
 

Veterans Administration Med Ctr
Washington D.C.,  District of Columbia,  20422
United States
 

San Juan Veterans Administration Med Ctr
San Juan,  ,  009275800
Puerto Rico
 

UCLA School of Medicine
Los Angeles,  California,  900121973
United States
 

West Paces Clinical Research Incoporated
Atlanta,  Georgia,  30327
United States
 

Saint Vincent's Hosp and Med Ctr
New York City,  New York,  10011
United States
 

UMDNJ - New Jersey Med School / Cooper Hosp
Camden,  New Jersey,  08103
United States
 


Additional Information:
Study ID Numbers:
  229A;  NV 14256B,NV 14256A
Study Start Date: 
Record last reviewed: February 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002333

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