Back to resultsTreatment of Psoriasis Using Acitretin in HIV-Positive Patients
Primary Purpose
HIV Infections, Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acitretin
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Psoriasis, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Acitretin
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Any nondermatologic medication. Patients must have: HIV infection. Psoriasis involving at least 10 percent of body surface.
Sites / Locations
- Beth Israel Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002143
Brief Title
Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Official Title
Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 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
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
To determine the efficacy of acitretin in the treatment of psoriasis in HIV/AIDS patients.
Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in treating psoriasis in patients without HIV infection by reducing skin involvement and clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.
Detailed Description
Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in treating psoriasis in patients without HIV infection by reducing skin involvement and clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.
Patients receive acitretin daily, with dose increases every 4 weeks based on quantitative assessment of the skin using the Psoriasis Area and Severity Index (PASI). Treatment continues for a total of 20 weeks. Patients are followed every 2 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Psoriasis
Keywords
Psoriasis, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Acitretin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Acitretin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Any nondermatologic medication.
Patients must have:
HIV infection.
Psoriasis involving at least 10 percent of body surface.
Facility Information:
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
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