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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002175
• Other study ID #: 265A
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Dinitrochlorobenzene

Locations

Country	Name	City	State
United States	Queen Emma Clinics / The Queen's Med Ctr	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
The Honolulu Medical Group

Country where clinical trial is conducted

United States,