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A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002334
  Purpose

To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Drug: Zidovudine
Drug: Zalcitabine
Phase III

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, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3

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

Estimated Enrollment:   3000

Detailed Description:

Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Erythropoietin and G-CSF.

Concurrent Treatment:

Allowed:

  • Local skin radiotherapy.

Patients must have:

  • HIV infection.
  • CD4 count 50 - 350 cells/mm3.
  • No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
  • No acute serious opportunistic infections requiring immediate treatment.
  • No unexplained fever persisting for 14 days within 90 days prior to study entry.
  • No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry.
  • No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy.
  • Life expectancy of at least 80 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malabsorption.
  • Severe chronic diarrhea.
  • Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).
  • Any grade 3 or worse toxicity.
  • Inability to comply with study requirements.

Concurrent Medication:

Excluded:

  • Other investigational agents.
  • Antineoplastic agents.
  • Biologic response modifiers (including interferons).
  • Foscarnet.
  • Anti-HIV drugs other than the study drugs.

Concurrent Treatment:

Excluded:

  • Radiotherapy (other than local skin radiotherapy).

Patients with the following prior condition are excluded:

History of non-Hodgkin's lymphoma.

Prior Medication:

Excluded:

  • Acute therapy for opportunistic infection within 14 days prior to study entry.
  • Prior HIV proteinase inhibitor.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002334

Show 26 study locations  Show 26 Study Locations

Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Publications:
Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60

Study ID Numbers:   229B, SV 14604C, SV 14604A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002334
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Zidovudine
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
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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