Treatment of Psoriasis Using Acitretin in HIV-Positive Patients - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002143

Purpose

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.

Condition	Intervention	Phase
HIV Infections Psoriasis	Drug: Acitretin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Placebo Control, Efficacy Study
Official Title:	Treatment of Psoriasis Using Acitretin in HIV-Positive Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Psoriasis

Drug Information available for: Acitretin

U.S. FDA Resources

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

Estimated Enrollment:

30

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Any nondermatologic medication.

Patients must have:

HIV infection.
Psoriasis involving at least 10 percent of body surface.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002143

Locations

United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Study ID Numbers:	239A, 65-93(2)
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002143 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Psoriasis
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Acitretin

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Skin Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Keratolytic Agents

Virus Diseases
HIV Infections
Psoriasis
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Dermatologic Agents
Acitretin
Skin Diseases, Papulosquamous
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009