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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002116
• Other study ID #: 218A
• Secondary ID: GS-93-301
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1995
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• HIV Infections

Intervention

Drug:
• Cidofovir

Locations

Country	Name	City	State
Canada	Univ of British Columbia / Univ Hosp	Vancouver	British Columbia
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Univ of North Carolina Hosps	Chapel Hill	North Carolina
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Park Plaza Hosp	Houston	Texas
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Mount Zion Med Ctr / UCSF	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Univ of Washington / Viral Disease Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5. — View Citation