A Study of DTC in Patients With AIDS and AIDS Related Complex

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Merieux Institute
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002069

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Ditiocarb sodium

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Study of DTC in Patients With AIDS and AIDS Related Complex

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ditiocarb sodium

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002069

Locations

United States, Arizona
Univ of Arizona / Arizona Cancer Ctr
Tucson, Arizona, United States, 85724
United States, California
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Portion Med Group
Sherman Oaks, California, United States, 91403
United States, Florida
Florida Keys Memorial Hosp
Key West, Florida, United States, 33040
United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Texas
Dr Gary Brewton
Houston, Texas, United States, 77027

Sponsors and Collaborators

Merieux Institute

More Information

Publications:

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)

ClinicalTrials.gov Identifier:	NCT00002069 History of Changes
Other Study ID Numbers:	010A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Ditiocarb
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
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
Ditiocarb
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012