Clinical Trial: A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

This study has been completed.

Sponsored by: Mylan Laboratories
Information provided by: AIDS Clinical Trials Information Service

Purpose

To determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Cysteamine
 Drug: Zidovudine
Phase II

MedlinePlus related topics:  AIDS

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

Further Study Details: 

Expected Total Enrollment:  300

Patients receive high or low doses of cysteamine plus AZT or placebo plus AZT. The target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. An initial cohort of 36 patients will be enrolled in a 10-week pilot phase. Accrual will be temporarily suspended while data from the pilot phase is assessed.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

  • Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator.
  • Recombinant erythropoietin and G-CSF if clinically indicated. Patients must have:
  • Documented HIV infection.
  • CD4 count 300 - 500 cells/mm3.
  • Prior AZT therapy for at least 3 months but less than 12 months prior to study entry.
  • No past or current AIDS-defining opportunistic infection.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

  • Kaposi's sarcoma requiring systemic therapy.
  • Active malignancy other than basal cell carcinoma or in situ cervical carcinoma. Concurrent Medication: Excluded:
  • Antiretroviral therapy other than AZT.
  • Immunosuppressive drugs.
  • Investigational HIV drugs/therapies other than study drug.
  • Interferon.
  • Steroids.
  • Hematopoietins.
  • Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine. Concurrent Treatment: Excluded:
  • Radiation therapy. Patients with the following prior condition are excluded: History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity. Prior Medication: Excluded:
  • Prior antiretroviral therapy other than AZT. Required:
  • AZT for at least 3 months but no more than 12 months prior to study entry.

Location Information


Florida
      Infectious Disease Research Institute Inc, Tampa,  Florida,  33614,  United States

Louisiana
      Tulane Univ Med School, New Orleans,  Louisiana,  701122699,  United States

New York
      SUNY / Health Sciences Ctr at Stony Brook, Stony Brook,  New York,  117948153,  United States

North Carolina
      Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem,  North Carolina,  271571042,  United States

Rhode Island
      Independent Research Nurses Inc, Cranston,  Rhode Island,  02910,  United States

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

More Information

Study ID Numbers:  211A; CYST-9304
Record last reviewed:  October 1995
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002110
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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