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A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease 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: NCT00002116
  Purpose

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.


Condition Intervention Phase
Herpes Simplex
HIV Infections
Drug: Cidofovir
Phase I

MedlinePlus related topics: AIDS Herpes Simplex
Drug Information available for: Cidofovir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

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

Estimated Enrollment: 30
Detailed Description:

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy with AZT, ddI, ddC, or d4T.
  • Oral trimethoprim/sulfamethoxazole.
  • Dapsone.
  • Atovaquone.
  • Fluconazole.
  • Rifabutin.
  • Clarithromycin.

Patients must have:

  • HIV seropositivity.
  • Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
  • Measurable lesions.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active medical problems sufficient to hinder study compliance or assessment of treatment effect.

Concurrent Medication:

Excluded:

  • Acyclovir.
  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs (except d4T).
  • Amphotericin.
  • Intravenous therapy for PCP.
  • Chemotherapeutic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs with potential anti-HSV activity.
  • Amphotericin.
  • Intravenous therapy for PCP.

Excluded within 4 weeks prior to study entry:

  • Chemotherapeutic agents.

Required:

  • At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).

Substance abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002116

Locations
United States, California
Mount Zion Med Ctr / UCSF
San Francisco, California, United States, 94115
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
United States, North Carolina
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Park Plaza Hosp
Houston, Texas, United States, 77004
United States, Washington
Univ of Washington / Viral Disease Clinic
Seattle, Washington, United States, 98122
Canada, British Columbia
Univ of British Columbia / Univ Hosp
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
Study ID Numbers: 218A, GS-93-301
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002116  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Herpes Simplex
Acquired Immunodeficiency Syndrome
Antiviral Agents
cidofovir

Study placed in the following topic categories:
Herpes Simplex
Cidofovir
Sexually Transmitted Diseases, Viral
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Skin Diseases, Infectious
HIV 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 January 14, 2009