A Study of DTC in Patients With AIDS and AIDS Related Com... | NCT00002069

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

NCT00002069

Sponsor

Merieux Institute

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

HIV Infections

Interventions

Ditiocarb sodium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 1989

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Ditiocarb sodium	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univ of Arizona / Arizona Cancer Ctr		Tucson	Arizona	85724	United States
USC School of Medicine / Norris Cancer Hosp

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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)

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome
D000386	AIDS-Related Complex

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D013859	Thiocarbamates
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids