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
Herpes Simplex, HIV Infections
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
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