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Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

This study has been completed.

Sponsored by: Gilead Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002181
  Purpose

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.


Condition Intervention
Herpes Simplex
HIV Infections
Drug: Cidofovir

MedlinePlus related topics:   AIDS    Herpes Simplex   

Drug Information available for:   Acyclovir    Acyclovir sodium    Cidofovir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Patients receive open-label treatment with cidofovir gel.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002181

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

Sponsors and Collaborators
Gilead Sciences
  More Information


Study ID Numbers:   218B, GS-96-307
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002181
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Herpes Simplex  
Acyclovir  
Antiviral Agents
Gels
cidofovir

Study placed in the following topic categories:
Cidofovir
Herpes Simplex
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Skin Diseases, Infectious
Acyclovir
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Antiviral Agents
Pharmacologic Actions
Skin Diseases, Viral
Anti-Retroviral Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on November 20, 2008




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