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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

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cidofovir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Herpes Simplex, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • UCSF - San Francisco Gen Hosp
  • Mount Zion Med Ctr / UCSF
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Johns Hopkins Hosp
  • Univ of North Carolina Hosps
  • Park Plaza Hosp
  • Univ of Washington / Viral Disease Clinic
  • Univ of British Columbia / Univ Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002116
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, HIV Infections
Keywords
Herpes Simplex, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cidofovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Mount Zion Med Ctr / UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Univ of North Carolina Hosps
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Park Plaza Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Univ of Washington / Viral Disease Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Univ of British Columbia / Univ Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11364104
Citation
Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5.
Results Reference
background

Learn more about this trial

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

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