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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002333
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1995
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Drug: Zalcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 900
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002333

  Hide Study Locations
Locations
United States, California
Kaiser Foundation Hosp
Harbor City, California, United States, 90710
UCSD
La Jolla, California, United States, 920930679
UCLA School of Medicine
Los Angeles, California, United States, 900121973
CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States, 90095
UCD
Sacramento, California, United States, 95817
Davies Med Ctr / c/o HIV Institute
San Francisco, California, United States, 94114
Mount Zion Med Ctr / UCSF
San Francisco, California, United States, 94115
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Pacific Oaks Med Group / Rsch & Scientific Investigation
Sherman Oaks, California, United States, 91403
Sunnyvale Med Clinic
Sunnyvale, California, United States, 94086
Harbor - UCLA Med Ctr
Torrance, California, United States, 90505
United States, District of Columbia
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
Univ of Miami Dept of Medicine
Miami, Florida, United States, 33136
Stratogen of South Florida
Miami Beach, Florida, United States, 33140
United States, Georgia
West Paces Clinical Research Incoporated
Atlanta, Georgia, United States, 30327
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Massachusetts Gen Hosp / Harvard Med School
Boston, Massachusetts, United States, 02114
New England Deaconess Hosp
Boston, Massachusetts, United States, 02215
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, Michigan
Harper Hosp
Detroit, Michigan, United States, 48201
United States, Missouri
Washington Univ School of Medicine
St. Louis, Missouri, United States, 63108
United States, New Jersey
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, United States, 08103
UMDNJ - New Jersy Med School
Newark, New Jersey, United States, 08103
United States, New York
Albany Med College
Albany, New York, United States, 12208
Harkness Pavilion
New York, New York, United States, 10032
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, Ohio
Ohio State Univ Hosp
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health Sciences Univ
Portland, Oregon, United States, 97201
United States, Pennsylvania
Thomas Jefferson Med College
Philadelphia, Pennsylvania, United States, 19107
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, United States, 19146
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Oaklawn Physicians Group
Dallas, Texas, United States, 75219
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550882
Baylor College of Medicine
Houston, Texas, United States, 77005
United States, Washington
Univ of Washington / Harborview Med Ctr
Seattle, Washington, United States, 98104
Canada, Alberta
Southern Alberta HIV Clinic
Calgary, Alberta, Canada
Canada, Ontario
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Canada, Quebec
Montreal Gen Hosp
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Puerto Rico
San Juan Veterans Administration Med Ctr
San Juan, Puerto Rico, 009275800
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002333     History of Changes
Other Study ID Numbers: 229A, NV 14256B, NV 14256A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Zalcitabine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Saquinavir
HIV Protease Inhibitors

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Saquinavir
Zalcitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014