HIV InfectionsNCT00002069
A Study of DTC in Patients With AIDS and AIDS Related Complex
A study testing Ditiocarb sodium in people with HIV Infections, run by Merieux Institute at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ditiocarb sodium
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Active opportunistic infection or progressive Kaposi's sarcoma (KS).
- Dementia.
- Lymphoma.
- Concurrent Medication:
Show all 11Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Duke Univ Med Ctr
Durham, North Carolina, 27710
Dr Gary Brewton
Houston, Texas, 77027
Florida Keys Memorial Hosp
Key West, Florida, 33040
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
Portion Med Group
Sherman Oaks, California, 91403
Univ of Arizona / Arizona Cancer Ctr
Tucson, Arizona, 85724
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Ditiocarb sodium
- Keywords
- Ditiocarb, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ditiocarb sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Merieux Institute
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002069
- Sponsor's protocol ID
- 010A
- Status last verified
- Jul 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of DTC in Patients With AIDS and AIDS Related Complex
- ClinicalTrials.gov ID
- NCT00002069
- Acronym / sponsor ID
- 010A
- Conditions
- HIV Infections
- Keywords
- Ditiocarb, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Merieux InstituteIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Zidovudine (AZT).
Key exclusion criteria (11 listed)
- Active opportunistic infection or progressive Kaposi's sarcoma (KS).
- Dementia.
- Lymphoma.
- Other experimental AIDS therapy.
- Active opportunistic infection or progressive Kaposi's sarcoma (KS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ditiocarb sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundHersh 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ditiocarb sodium in people with HIV Infections, run by Merieux Institute at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.