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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.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002333
  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 II

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Zidovudine    Zalcitabine    Saquinavir    Saquinavir mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
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

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

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

Show 47 study locations  Show 47 Study Locations

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)

Study ID Numbers:   229A, NV 14256B, NV 14256A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002333
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Saquinavir
HIV Infections
Zalcitabine
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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