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Trial record 19 of 32 for:    CYSTEAMINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002110
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Cysteamine Drug: Zidovudine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


  • 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:


  • Prior antiretroviral therapy other than AZT.


  • AZT for at least 3 months but no more than 12 months prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002110

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

Layout table for additonal information Identifier: NCT00002110     History of Changes
Other Study ID Numbers: 211A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 1995
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
AIDS-Related Complex
Additional relevant MeSH terms:
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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
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cystine Depleting Agents