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

Sponsor
The Honolulu Medical Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002175
Collaborator
(none)
46
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen Emma Clinics / The Queen's Med Ctr Honolulu Hawaii United States 96813

    Sponsors and Collaborators

    • The Honolulu Medical Group

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002175
    Other Study ID Numbers:
    • 265A
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jan 1, 1999

    Study Results

    No Results Posted as of Jun 24, 2005