A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002286
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1989
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Retrovir Capsules in the Treatment of Psoriasis in HIV Antibody Positive Patients: A Pilot Study

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Psoriasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014