Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.

NCT ID: NCT00002175

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

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of possible alterations in the immunological status of the HIV+ patient cohort.

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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Dinitrochlorobenzene

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* EITHER HIV negative or documented HIV+ by both the ELISA and Western blot tests.

For HIV+ patients:

* Patients must fail to meet the AIDS-defining criteria.
* CD4 lymphocyte count between 200 - 500 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Excluded:

Patients with obvious ultra violet(UV)-irradiated skin damage in the treatment sites.

Concurrent Medication:

Excluded:

* Patients who are likely to commence antiretrovirals within the 6-month study period.
* Patients using other immunomodulator therapies or other alternative therapies.
* Patients likely to require chemotherapy during the course of the study.

Concurrent Treatment:

Excluded:

* Patients who are likely to require significant UV light exposure during the study period.
* Patients who are likely to require radiation therapy during the course of the study.

Prior Medication:

Excluded:

* Prior exposure to DNCB.
* Patients who have used antiretroviral medications within the previous 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Honolulu Medical Group

OTHER

Sponsor Role lead

Locations

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Queen Emma Clinics / The Queen's Med Ctr

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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265A

Identifier Type: -

Identifier Source: org_study_id