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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

NCT ID: NCT00002116

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Herpes Simplex HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cidofovir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Locations

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Mount Zion Med Ctr / UCSF

San Francisco, California, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Univ of North Carolina Hosps

Chapel Hill, North Carolina, United States

Site Status

Park Plaza Hosp

Houston, Texas, United States

Site Status

Univ of Washington / Viral Disease Clinic

Seattle, Washington, United States

Site Status

Univ of British Columbia / Univ Hosp

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

References

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

Reference Type BACKGROUND
PMID: 11364104 (View on PubMed)

Other Identifiers

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GS-93-301

Identifier Type: -

Identifier Source: secondary_id

218A

Identifier Type: -

Identifier Source: org_study_id