Back to resultsA Study of DTC in Patients With AIDS and AIDS Related Complex
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ditiocarb sodium
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Ditiocarb, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Active opportunistic infection or progressive Kaposi's sarcoma (KS). Dementia. Lymphoma. Concurrent Medication: Excluded within 3 weeks of study entry: Other experimental AIDS therapy. Patients with the following are excluded: Active opportunistic infection or progressive Kaposi's sarcoma (KS). Patients must be either HIV seropositive or have AIDS or AIDS related complex (ARC) and have life expectancy of at least 6 months.
Sites / Locations
- Univ of Arizona / Arizona Cancer Ctr
- USC School of Medicine / Norris Cancer Hosp
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Portion Med Group
- Florida Keys Memorial Hosp
- SUNY / Health Sciences Ctr at Brooklyn
- Duke Univ Med Ctr
- Dr Gary Brewton
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002069
Brief Title
A Study of DTC in Patients With AIDS and AIDS Related Complex
Official Title
A Study of DTC in Patients With AIDS and AIDS Related Complex
Study Type
Interventional
2. Study Status
Record Verification Date
July 1989
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
Merieux Institute
4. Oversight
5. Study Description
Brief Summary
To determine if ditiocarb sodium (sodium diethyldithiocarbamate; DTC) restores immune and host defense function; if DTC ameliorates the AIDS related complex (ARC) symptoms in patients with AIDS and ARC; if DTC prevents progression from ARC to AIDS or progression of AIDS; and if DTC prolongs survival in AIDS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Ditiocarb, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ditiocarb sodium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Zidovudine (AZT).
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Active opportunistic infection or progressive Kaposi's sarcoma (KS).
Dementia.
Lymphoma.
Concurrent Medication:
Excluded within 3 weeks of study entry:
Other experimental AIDS therapy.
Patients with the following are excluded:
Active opportunistic infection or progressive Kaposi's sarcoma (KS).
Patients must be either HIV seropositive or have AIDS or AIDS related complex (ARC) and have life expectancy of at least 6 months.
Facility Information:
Facility Name
Univ of Arizona / Arizona Cancer Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
USC School of Medicine / Norris Cancer Hosp
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Portion Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Florida Keys Memorial Hosp
City
Key West
State/Province
Florida
ZIP/Postal Code
33040
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Dr Gary Brewton
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Hersh EM, et al. A randomized, double-blind, placebo-controlled trial of diethyldithiocarbamate (Ditiocarb, Imuthiol(R) in patients with ARC and AIDS. Int Conf AIDS. 1990 Jun 20-23;6(3):208 (abstract no SB489)
Results Reference
background
Learn more about this trial
A Study of DTC in Patients With AIDS and AIDS Related Complex
We'll reach out to this number within 24 hrs