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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dinitrochlorobenzene
Sponsored by
The Honolulu Medical Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Cohort Studies, RNA, Viral, Administration, Cutaneous, Anti-HIV Agents, Dinitrobenzenes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Queen Emma Clinics / The Queen's Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
The Honolulu Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT00002175
Brief Title
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
Official Title
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
January 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Honolulu Medical Group

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Cohort Studies, RNA, Viral, Administration, Cutaneous, Anti-HIV Agents, Dinitrobenzenes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
46 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dinitrochlorobenzene

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Queen Emma Clinics / The Queen's Med Ctr
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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