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

Completed · Phase 1

Conditions studied: Herpes Simplex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002116

Run by

Gilead Sciences

People needed

30

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.