Clinical trial NCT00002116: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Simplex
HIV Infections
Keywords: Herpes Simplex
Acquired Immunodeficiency Syndrome
Antiviral Agents
cidofovir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Mount Zion Med Ctr / UCSF
state: California
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Chapel Hill
country: United States
facility: Univ of North Carolina Hosps
state: North Carolina
city: Houston
country: United States
facility: Park Plaza Hosp
state: Texas
city: Seattle
country: United States
facility: Univ of Washington / Viral Disease Clinic
state: Washington
city: Vancouver
country: Canada
facility: Univ of British Columbia / Univ Hosp
state: British Columbia
Study officials:
References:
citation: Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5.