A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
Clinical Trial: A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
This study has been completed.
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 |
|Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Pharmacokinetics Study
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.
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
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.
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.
- 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.
Infectious Disease Research Institute Inc, Tampa, Florida, 33614, United States
Tulane Univ Med School, New Orleans, Louisiana, 701122699, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York, 117948153, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem, North Carolina, 271571042, United States
Independent Research Nurses Inc, Cranston, Rhode Island, 02910, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas, 75235, United States
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
Cache Date: April 9, 2005