Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

June 23, 2005 updated by: Gilead Sciences

Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.

The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive open-label treatment with cidofovir gel.

Study Type

Interventional

Phase

  • Not Applicable

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

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Mem Med Group Inc
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation Labs
      • Oceanside, California, United States, 92054
        • Sharp Mission Park / Med Group
      • San Diego, California, United States, 92103
        • Park Ctr for Health / Keith Vrhel
      • San Francisco, California, United States, 94107
        • Potrero Hill Med Ctr
      • Santa Rosa, California, United States, 95404
        • HIV Primary Care & Consult
    • Florida
      • Maitland, Florida, United States, 32751
        • Central Florida Research Initiative
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Braude Mermin Spivey MD PC
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Christie Clinic / Urbana Campus
    • Massachusetts
      • Gardner, Massachusetts, United States, 01440
        • Heywood Memorial Hosp
    • New York
      • New York, New York, United States, 10002
        • Gouverneur Hosp
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75225
        • Dr Nicholaos Bellos
      • Dallas, Texas, United States, 75225
        • Dr Susan M Diamond
      • Dallas, Texas, United States, 75231
        • ID Associates

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

Patients must have:

  • AIDS diagnosis per CDC criteria.
  • At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
  • Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
  • Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).

Concurrent Medication:

Excluded:

Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.

Required:

>= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).

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: None (Open Label)

Collaborators and Investigators

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

Sponsor

Gilead Sciences

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

November 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218B
  • GS-96-307

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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