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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cysteamine
Zidovudine
Sponsored by
Mylan Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Cysteamine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Infectious Disease Research Institute Inc
  • Tulane Univ Med School
  • SUNY / Health Sciences Ctr at Stony Brook
  • Bowman Gray School of Medicine / North Carolina Baptist Hosp
  • Independent Research Nurses Inc
  • Univ of Texas Southwestern Med Ctr of Dallas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Mylan Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002110
Brief Title
A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Official Title
A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mylan Laboratories

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Cysteamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cysteamine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Bowman Gray School of Medicine / North Carolina Baptist Hosp
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
271571042
Country
United States
Facility Name
Independent Research Nurses Inc
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02910
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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