A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002307
First received: November 2, 1999
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.


Condition Intervention
HIV Infections
Drug: Stavudine
Drug: Zidovudine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Completion Date: December 1994
  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT.

Patients must have:

  • Documented HIV infection as determined by a positive ELISA and/or Western blot.
  • Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.
  • Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.
  • Need for chronic systemic therapy at time of enrollment.
  • Intractable diarrhea.
  • Signs or symptoms of bilateral peripheral neuropathy at time of screening.
  • Demonstrated intolerance to zidovudine therapy.
  • Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

  • Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.

Patients with the following prior conditions are excluded:

  • Prior history of bilateral peripheral neuropathy.
  • Demonstrated intolerance to zidovudine therapy.

Prior Medication:

Excluded:

  • Prior d4T, ddI, or ddC.
  • Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).
  • Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.
  • Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.

Required:

  • At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.
  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: NCT00002307

  Show 45 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: . ., . .
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002307     History of Changes
Other Study ID Numbers: 116A, AI455-019
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:
Zidovudine
Stavudine

Additional relevant MeSH terms:
Infection
Communicable Diseases
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
Zidovudine
Stavudine
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 September 30, 2014