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

NCT ID: NCT00002069

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ditiocarb sodium

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merieux Institute

INDUSTRY

Sponsor Role lead

Locations

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Univ of Arizona / Arizona Cancer Ctr

Tucson, Arizona, United States

Site Status

USC School of Medicine / Norris Cancer Hosp

Los Angeles, California, United States

Site Status

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Portion Med Group

Sherman Oaks, California, United States

Site Status

Florida Keys Memorial Hosp

Key West, Florida, United States

Site Status

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, United States

Site Status

Duke Univ Med Ctr

Durham, North Carolina, United States

Site Status

Dr Gary Brewton

Houston, Texas, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

Other Identifiers

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010A

Identifier Type: -

Identifier Source: org_study_id