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Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002181
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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

Study Type: Interventional
Study Design: 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 NLM:


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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00002181


Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00002181     History of Changes
Other Study ID Numbers: 218B
GS-96-307
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: November 1997

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

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
Acyclovir
Cidofovir
Antiviral Agents
Anti-Infective Agents