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

June 23, 2005 updated by: Mylan Laboratories
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ Med School
    • New York
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • North Carolina
      • Winston Salem, North Carolina, United States, 271571042
        • Bowman Gray School of Medicine / North Carolina Baptist Hosp
    • Rhode Island
      • Cranston, Rhode Island, United States, 02910
        • Independent Research Nurses Inc
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211A
  • CYST-9304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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