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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002175
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1999
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Dinitrochlorobenzene
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 46
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002175

Locations
United States, Hawaii
Queen Emma Clinics / The Queen's Med Ctr
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
The Honolulu Medical Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002175     History of Changes
Other Study ID Numbers: 265A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Cohort Studies
RNA, Viral
Administration, Cutaneous
Anti-HIV Agents
Dinitrobenzenes

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013