Completed

Acitretin Therapy for Psoriasis in HIV-Positive Individuals

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Study Aim

This phase 3 study aims to evaluate the effectiveness of Acitretin therapy for treating psoriasis in individuals who are HIV-positive.

What is being tested

Acitretin

Drug
Who is being recruted

Blood-Borne Infections+18

+ Urogenital Diseases

+ Genital Diseases

From 18 to 55 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002143
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousAcquired Immunodeficiency SyndromeAIDS-Related ComplexPsoriasisHIV Infections

Criteria

3 inclusion criteria required to participate
Psoriasis involving at least 10 percent of body surface.

Allowed: Any nondermatologic medication.

HIV infection.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Beth Israel Med Ctr

New York, United StatesOpen Beth Israel Med Ctr in Google Maps
CompletedOne Study Center