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
  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 3

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

Resource links provided by NLM:


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
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: NCT00002334

  Hide Study Locations
Locations
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
United States, California
UCD Med Ctr
Sacramento, California, United States, 95817
Davies Med Ctr
San Francisco, California, United States, 94114
Mount Zion Med Ctr / UCSF
San Francisco, California, United States, 94115
Pacific Oaks Med Group
Sherman Oaks, California, United States, 91403
Sunnyvale Med Clinic
Sunnyvale, California, United States, 94086
United States, District of Columbia
Howard Univ
Washington, District of Columbia, United States, 20060
Novum Inc
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699
United States, Massachusetts
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
United States, Nevada
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, United States, 89102
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
Harkness Pavilion
New York, New York, United States, 10032
United States, Ohio
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Univ of Oklahoma Health Science / Pharmacy Practice
Oklahoma City, Oklahoma, United States, 73117
United States, Pennsylvania
Novum Inc
Pittsburgh, Pennsylvania, United States, 152063817
United States, Texas
Respiratory Associates
Corpus Christi, Texas, United States, 78404
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States, 75219
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550882
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, United States, 77009
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224379
Puerto Rico
San Juan Veterans Administration Med Ctr
San Juan, Puerto Rico, 009275800
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

ClinicalTrials.gov Identifier: NCT00002334     History of Changes
Other Study ID Numbers: 229B, SV 14604C, SV 14604A
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:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Saquinavir
HIV Protease Inhibitors

Additional relevant MeSH terms:
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
Zalcitabine
Zidovudine
Saquinavir
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on July 10, 2014