A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

June 23, 2005 updated by: Gilead Sciences
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Univ of British Columbia / Univ Hosp
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
      • San Francisco, California, United States, 94115
        • Mount Zion Med Ctr / UCSF
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hosp
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Univ of North Carolina Hosps
    • Texas
      • Houston, Texas, United States, 77004
        • Park Plaza Hosp
    • Washington
      • Seattle, Washington, United States, 98122
        • Univ of Washington / Viral Disease Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy with AZT, ddI, ddC, or d4T.
  • Oral trimethoprim/sulfamethoxazole.
  • Dapsone.
  • Atovaquone.
  • Fluconazole.
  • Rifabutin.
  • Clarithromycin.

Patients must have:

  • HIV seropositivity.
  • Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
  • Measurable lesions.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active medical problems sufficient to hinder study compliance or assessment of treatment effect.

Concurrent Medication:

Excluded:

  • Acyclovir.
  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs (except d4T).
  • Amphotericin.
  • Intravenous therapy for PCP.
  • Chemotherapeutic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs with potential anti-HSV activity.
  • Amphotericin.
  • Intravenous therapy for PCP.

Excluded within 4 weeks prior to study entry:

  • Chemotherapeutic agents.

Required:

  • At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).

Substance abuse.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218A
  • GS-93-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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