Clinical Trial: 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.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

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 Treatment or Intervention
HIV Infections
 Drug: Zidovudine
 Drug: Didanosine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

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:

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.

Location Information


Arizona
      Univ of Arizona / Health Science Ctr, Tucson,  Arizona,  85724,  United States

Connecticut
      Yale Univ Med School, New Haven,  Connecticut,  06510,  United States

Florida
      G E Morey Jr, Fort Lauderdale,  Florida,  33316,  United States

      VP Med Services / HHCS Research Institute Inc, Orlando,  Florida,  32806,  United States

Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States

Illinois
      Edward Hines Veterans Administration Hosp, Hines,  Illinois,  60141,  United States

Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States

Michigan
      Harper Hosp, Detroit,  Michigan,  48201,  United States

New York
      Albany Med College / AIDS Treatment Ctr, Albany,  New York,  12203,  United States

Ohio
      Med College of Ohio, Toledo,  Ohio,  43699,  United States

Pennsylvania
      Univ of Pennsylvania / HIV Clinic, Philadelphia,  Pennsylvania,  19104,  United States

Texas
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States

      Audie L Murphy Veterans Administration Hosp, San Antonio,  Texas,  78284,  United States

      Univ TX Galveston Med Branch, Galveston,  Texas,  775550882,  United States

Utah
      Univ of Utah School of Medicine, Salt Lake City,  Utah,  84132,  United States

Virginia
      Dr Stephen L Green, Hampton,  Virginia,  23666,  United States

Wisconsin
      Milwaukee County Med Complex, Milwaukee,  Wisconsin,  53226,  United States

Puerto Rico
      UPR School of Medicine, San Juan,  009275800,  Puerto Rico

More 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)

Study ID Numbers:  039B; AI454-010
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002035
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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