NCT00002069

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

DitiocarbAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Ditiocarb sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Univ of Arizona / Arizona Cancer Ctr

Tucson, Arizona, 85724, United States

Location

USC School of Medicine / Norris Cancer Hosp

Los Angeles, California, 90033, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Portion Med Group

Sherman Oaks, California, 91403, United States

Location

Florida Keys Memorial Hosp

Key West, Florida, 33040, United States

Location

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, 11203, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Dr Gary Brewton

Houston, Texas, 77027, United States

Location

Related Publications (1)

  • 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)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Ditiocarb

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThiocarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-07

Locations

US(8)