HIV InfectionsPhase 1NCT00002175
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
A Phase 1 study testing Dinitrochlorobenzene in people with HIV Infections, run by The Honolulu Medical Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dinitrochlorobenzene
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Queen Emma Clinics / The Queen's Med Ctr
Honolulu, Hawaii, 96813
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Dinitrochlorobenzene
- Keywords
- Cohort Studies, RNA, Viral, Administration, Cutaneous, Anti-HIV Agents, Dinitrobenzenes
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinitrochlorobenzeneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- The Honolulu Medical Group
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002175
- Sponsor's protocol ID
- 265A
- Status last verified
- Jan 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
- ClinicalTrials.gov ID
- NCT00002175
- Acronym / sponsor ID
- 265A
- Conditions
- HIV Infections
- Keywords
- Cohort Studies, RNA, Viral, Administration, Cutaneous, Anti-HIV Agents, Dinitrobenzenes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- The Honolulu Medical GroupUniversity, hospital or other
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- EITHER HIV negative or documented HIV+ by both the ELISA and Western blot tests.
- Patients must fail to meet the AIDS-defining criteria.
- CD4 lymphocyte count between 200 - 500 cells/mm3.
Key exclusion criteria (16 listed)
- Patients with obvious ultra violet(UV)-irradiated skin damage in the treatment sites.
- 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.
- Patients who are likely to require significant UV light exposure during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dinitrochlorobenzene | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dinitrochlorobenzene in people with HIV Infections, run by The Honolulu Medical Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.