Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001040
First received: November 2, 1999
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC.

SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Drug: Zidovudine
Drug: Zalcitabine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
Primary Completion Date: May 1994 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Prior Medication: Required:

  • At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.

Patients must have:

  • HIV seropositivity.
  • Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
  • CD4 count > 50 to <= 300 cells/mm3.
  • Life expectancy of at least 6 months.
  • Prior AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
  • Known intolerance to Ro 31-8959, AZT, or ddC.
  • Symptoms suggestive of pancreatitis.
  • Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
  • Visceral Kaposi's sarcoma.
  • Lymphoma that will require therapy within the next 6 months.
  • Transfusion dependence.

Concurrent Medication:

Excluded:

  • Investigational or antineoplastic agents.

Concurrent Treatment:

Excluded:

  • Radiotherapy (other than local skin radiotherapy).
  • Transfusions.

Prior Medication:

Excluded:

  • Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry.
  • Prior treatment with an HIV proteinase inhibitor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001040

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
United States, Ohio
Ohio State Univ Hosp
Columbus, Ohio, United States, 432101228
United States, Pennsylvania
Girard Med Ctr
Philadelphia, Pennsylvania, United States, 191046073
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550882
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Collier AC
Study Chair: Corey L
  More Information

Additional Information:
Publications:
Brambilla D, Coombs R, Bremer JW, Reichelderfer PS, Kalish L, Shapiro DE. The contributions of assay variation and biological variation to the variability of HIV RNA measurements in serially collected clinical specimens. Int Conf AIDS. 1998;12:805 (abstract no 42163)
Collier AC, Coombs RW, Timpone J, Schoenfeld DA, Bassett R, Baruch A, Corey L. Comparative study of Ro 31-8959 and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. Ro 31-8959, ZDV, and ddC. The ACTG 229 Protocol Team. Int Conf AIDS. 1994 Aug 7-12;10(1):21 (abstract no 058B)
Schapiro JM, Lawrence J, Speck R, Winters MA, Coombs R, Collier AC, Efron B, Merigan TC. HIV RNA and resistance mutations to saquinavir and zidovudine in patients receiving dual versus triple combination therapy. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:154 (abstract no 401)

ClinicalTrials.gov Identifier: NCT00001040     History of Changes
Other Study ID Numbers: ACTG 229, NV14255D, FDA 123A
Study First Received: November 2, 1999
Last Updated: February 28, 2011
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Zalcitabine
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 April 14, 2014