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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002334
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002334 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Saquinavir
  • Drug: Zidovudine
  • Drug: Zalcitabine
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00002334
229B, SV 14604C, SV 14604A
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Hoffmann-La Roche
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Not Provided
NIH AIDS Clinical Trials Information Service
September 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP