NCT00002175

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Cohort StudiesRNA, ViralAdministration, CutaneousAnti-HIV AgentsDinitrobenzenes

Interventions

DinitrochlorobenzeneDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Emma Clinics / The Queen's Med Ctr

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Dinitrochlorobenzene

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChlorobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsNitrobenzenesHydrocarbons, ChlorinatedHydrocarbons, HalogenatedDinitrobenzenesNitro CompoundsHaptensEpitopesAntigensBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-01

Locations

US(1)