Search / Trial NCT00002333

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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Saquinavir Hiv Protease Inhibitors

ClinConnect Summary

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.)

Gender

ALL

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.

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Houston, Texas, United States

San Francisco, California, United States

New York, New York, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Atlanta, Georgia, United States

Miami, Florida, United States

Harbor City, California, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

New York, New York, United States

Montreal, Quebec, Canada

San Juan, , Puerto Rico

Boston, Massachusetts, United States

San Francisco, California, United States

Detroit, Michigan, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Galveston, Texas, United States

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

Toronto, Ontario, Canada

Camden, New Jersey, United States

Columbus, Ohio, United States

Portland, Oregon, United States

Memphis, Tennessee, United States

Miami Beach, Florida, United States

Atlanta, Georgia, United States

Miami, Florida, United States

San Francisco, California, United States

Sunnyvale, California, United States

Torrance, California, United States

Wichita, Kansas, United States

Los Angeles, California, United States

Hamilton, Ontario, Canada

Sherman Oaks, California, United States

Dallas, Texas, United States

Montreal, Quebec, Canada

Albany, New York, United States

St. Louis, Missouri, United States

Philadelphia, Pennsylvania, United States

La Jolla, California, United States

Sacramento, California, United States

Newark, New Jersey, United States

New York, New York, United States

Seattle, Washington, United States

Calgary, Alberta, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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