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Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cidofovir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring AIDS-Related Opportunistic Infections, Herpes Simplex, Acyclovir, Antiviral Agents, Gels, cidofovir

Eligibility Criteria

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

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).

Sites / Locations

  • Mem Med Group Inc
  • AIDS Healthcare Foundation Labs
  • Sharp Mission Park / Med Group
  • Park Ctr for Health / Keith Vrhel
  • Potrero Hill Med Ctr
  • HIV Primary Care & Consult
  • Central Florida Research Initiative
  • Braude Mermin Spivey MD PC
  • Christie Clinic / Urbana Campus
  • Heywood Memorial Hosp
  • Gouverneur Hosp
  • Central Texas Med Foundation
  • Dr Nicholaos Bellos
  • Dr Susan M Diamond
  • ID Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT00002181
Brief Title
Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
Official Title
Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.
Study Type
Interventional

2. Study Status

Record Verification Date
November 1997
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
Gilead Sciences

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
Patients receive open-label treatment with cidofovir gel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Herpes Simplex, Acyclovir, Antiviral Agents, Gels, cidofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cidofovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Mem Med Group Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
AIDS Healthcare Foundation Labs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Sharp Mission Park / Med Group
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
Park Ctr for Health / Keith Vrhel
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Potrero Hill Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
HIV Primary Care & Consult
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95404
Country
United States
Facility Name
Central Florida Research Initiative
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Braude Mermin Spivey MD PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Christie Clinic / Urbana Campus
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Heywood Memorial Hosp
City
Gardner
State/Province
Massachusetts
ZIP/Postal Code
01440
Country
United States
Facility Name
Gouverneur Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10002
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Dr Nicholaos Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
Dr Susan M Diamond
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
ID Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

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Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

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