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A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients
This study has been completed.
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002286
  Purpose

To evaluate the feasibility of Retrovir (AZT) in the treatment of psoriasis in HIV antibody positive patients. Retrovir has been shown to be effective in the treatment of AIDS. In addition, the administration of AZT appears to have induced a remission of psoriasis in one case study. In light of AZT's antiviral activity and potential effectiveness as an agent for the treatment of psoriasis, this would be the most likely treatment for HIV positive, psoriatic patients whose disease progresses quickly.


Condition Intervention
HIV Infections
Psoriasis
Drug: Zidovudine

MedlinePlus related topics: AIDS Psoriasis
Drug Information available for: Zidovudine Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: Retrovir Capsules in the Treatment of Psoriasis in HIV Antibody Positive Patients: A Pilot Study
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Study participants must have biopsy-proven psoriasis with 3 distinct psoriatic lesions. (Biopsy-proven Reiter's syndrome patients with 3 distinct cutaneous lesions may be included.) Documented HIV antibody (by federally licensed ELISA test) positive patients.

Prior Medication:

Allowed:

  • Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Presence of any active opportunistic infection.
  • Presence of any AIDS-defining neoplasms (excluding Kaposi's sarcoma) such as central nervous system (CNS) lymphoma.
  • Known hypersensitivity to zidovudine (AZT).
  • Impaired renal function.
  • Significant hepatic dysfunction.

Concurrent Medication:

Excluded:

- Topical steroid, anthralin, or tar preparations. Etretinate, methotrexate, or psoralen ultraviolet A (PUVA) therapy. Psoriatic treatment such as systemic agents or topical steroids (emollients used distal to the control lesions and antipruritic shampoos are admissible).

Patients with the following are excluded:

  • Presence of any active opportunistic infection.
  • Presence of any AIDS-defining neoplasms (excluding Kaposi's sarcoma) such as central nervous system (CNS) lymphoma.
  • Known hypersensitivity to zidovudine (AZT).
  • Impaired renal function.
  • Significant hepatic dysfunction.

Prior Medication:

Excluded:

  • Other antiretroviral agents (e.g., suramin, ribavirin, HPA-23, dideoxycytidine).
  • Excluded within 2 weeks of study entry:
  • Topical steroid, anthralin, or tar preparations.
  • Any other experimental therapy drugs which cause significant bone marrow suppression such as antifolates or pyrimethamine.
  • Cytolytic chemotherapy.
  • Drugs which cause significant nephrotoxicity or hepatotoxicity.
  • Rifampin or rifampin derivatives.
  • Excluded within 4 weeks of study entry:
  • Etretinate, methotrexate, or psoralen ultraviolet A (PUVA) therapy.
  • Excluded within 8 weeks of study entry:
  • Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002286

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Glaxo Wellcome
  More Information

Study ID Numbers: 014F, 16
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002286  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Pilot Projects
Psoriasis
Acquired Immunodeficiency Syndrome
Zidovudine

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
HIV Antibodies
Skin Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Immunologic Deficiency Syndromes
Virus Diseases
Antibodies
HIV Seropositivity
HIV Infections
Psoriasis
Sexually Transmitted Diseases
Retroviridae Infections
Skin Diseases, Papulosquamous
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009