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

Primary Purpose

HIV Infections, Psoriasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pilot Projects, Psoriasis, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glaxo Wellcome Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002286
Brief Title
A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients
Official Title
Retrovir Capsules in the Treatment of Psoriasis in HIV Antibody Positive Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 1989
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
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Psoriasis
Keywords
Pilot Projects, Psoriasis, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Glaxo Wellcome Inc
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

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

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