Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002181
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1997

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002181 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
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.

Patients receive open-label treatment with cidofovir gel.

Interventional
Not Provided
Masking: Open Label
Primary Purpose: Treatment
  • Herpes Simplex
  • HIV Infections
Drug: Cidofovir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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).

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002181
218B, GS-96-307
Not Provided
Not Provided
Gilead Sciences
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
November 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP