Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002035
First received: November 2, 1999
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.


Condition Intervention
HIV Infections
Drug: Zidovudine
Drug: Didanosine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 300
Study Completion Date: April 1992
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed for Hematologic toxicity:

  • Erythropoietin.
  • Colony-Stimulating Factors.
  • Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):
  • Aerosolized pentamidine.
  • Trimethoprim/sulfamethoxazole.
  • Dapsone.
  • NOTE:
  • If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine.
  • Allowed:
  • Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol).

Concurrent Treatment:

Allowed:

  • Transfusions for hematologic toxicity.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Active acute AIDS defining infection.
  • Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.
  • Dementia of such severity that patient cannot give informed consent.
  • Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).
  • Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.
  • Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy.
  • Cardiomyopathy or the need for antiarrhythmic therapy.
  • Inability to tolerate at least 600 mg per day of zidovudine (AZT).
  • Seizures within the last 6 months or the need for anticonvulsant therapy.

Concurrent Medication:

Excluded:

  • Ganciclovir (DHPG).
  • Myelosuppressive or neurotoxic chemotherapy.
  • Antiarrhythmic therapy.
  • Anticonvulsant therapy.
  • Neurotoxic agents (as defined in the protocol).
  • NOTE:
  • If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine.

Patients with the following are excluded:

  • Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field.
  • Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry > 300 cells/mm3.

Prior Medication:

Excluded, participation in studies using:

  • Dideoxyinosine (ddI).
  • 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T).
  • Dideoxycytidine (ddC).
  • Excluded within one month of study entry:
  • Any other experimental antiretroviral compounds.

Patients must:

  • Have documented HIV positivity via ELISA.
  • Meet CDC criteria for AIDS or AIDS related complex (ARC).
  • Have received zidovudine (AZT) for = or > 6 months and tolerated a dose of at least 500 mg per day without significant hematologic toxicity.
  • Have no acute AIDS defining opportunistic infection, but may be receiving suppressive therapy for such infections.
  • Demonstrate at least one of the following criteria for clinical deterioration despite AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss):
  • involuntary weight loss of more than 5 percent of the body weight occurring over the 8 week period prior to study entry, Karnofsky score = or > 50 but demonstrating a fall = or > 20 from previous level of functioning (assessment must be persistent on two occasions at least 14 days apart), unexplained fever of = or > 38 degrees C (despite evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent multidermatomal varicella-zoster, appearance of dermatologic afflictions (e.g. psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis), appearance of chronic herpetic ulcers not responsive to acyclovir therapy.

Required:

  • Zidovudine (AZT) for = or > 6 months prior to study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002035

Locations
United States, Arizona
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
United States, Connecticut
Yale Univ Med School
New Haven, Connecticut, United States, 06510
United States, Florida
G E Morey Jr
Fort Lauderdale, Florida, United States, 33316
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, United States, 32806
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Edward Hines Veterans Administration Hosp
Hines, Illinois, United States, 60141
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Michigan
Harper Hosp
Detroit, Michigan, United States, 48201
United States, New York
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States, 12203
United States, Ohio
Med College of Ohio
Toledo, Ohio, United States, 43699
United States, Pennsylvania
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550882
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
United States, Utah
Univ of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Dr Stephen L Green
Hampton, Virginia, United States, 23666
United States, Wisconsin
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
UPR School of Medicine
San Juan, Puerto Rico, 009275800
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Ruedy N, et al. Results of long term follow-up of a double blind study of ddI vs continued AZT among individuals with CD4s 200-500/mm3. Int Conf AIDS. 1994 Aug 7-12;10(2):16 (abstract no 358B)

ClinicalTrials.gov Identifier: NCT00002035     History of Changes
Other Study ID Numbers: 039B, AI454-010
Study First Received: November 2, 1999
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Didanosine
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
AIDS-Related Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Didanosine
Zidovudine
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

ClinicalTrials.gov processed this record on April 15, 2014