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

Launched by GILEAD SCIENCES · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

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.