ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
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.
Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief 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
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
Brief Summary

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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Double-Blind, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Herpes Simplex
HIV Infections
Intervention  Drug: Cidofovir
MEDLINE PMIDs 11364104
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  30
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00002116
Organization ID 218A
Secondary IDs †† GS-93-301
Study Sponsor  Gilead Sciences
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date December 1995
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers