Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002181
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Herpes Simplex HIV Infections Drug: Cidofovir Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.

Resource links provided by the National Library of Medicine

Drug Information available for: Cidofovir

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


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


>= 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002181

United States, California
Mem Med Group Inc
Long Beach, California, United States, 90806
AIDS Healthcare Foundation Labs
Los Angeles, California, United States, 90027
Sharp Mission Park / Med Group
Oceanside, California, United States, 92054
Park Ctr for Health / Keith Vrhel
San Diego, California, United States, 92103
Potrero Hill Med Ctr
San Francisco, California, United States, 94107
HIV Primary Care & Consult
Santa Rosa, California, United States, 95404
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
Central Texas Med Foundation
Austin, Texas, United States, 78751
Dr Nicholaos Bellos
Dallas, Texas, United States, 75225
Dr Susan M Diamond
Dallas, Texas, United States, 75225
ID Associates
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Gilead Sciences Identifier: NCT00002181     History of Changes
Other Study ID Numbers: 218B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 1997

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

Additional relevant MeSH terms:
HIV Infections
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents