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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002069
Other study ID # 010A
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date July 1989
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ditiocarb sodium


Locations

Country Name City State
United States SUNY / Health Sciences Ctr at Brooklyn Brooklyn New York
United States Duke Univ Med Ctr Durham North Carolina
United States Dr Gary Brewton Houston Texas
United States Florida Keys Memorial Hosp Key West Florida
United States USC School of Medicine / Norris Cancer Hosp Los Angeles California
United States San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California
United States Portion Med Group Sherman Oaks California
United States Univ of Arizona / Arizona Cancer Ctr Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Merieux Institute

Country where clinical trial is conducted

United States, 

References & 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)

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