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
- Conditions
- Herpes SimplexHIV Infections
- Registration Number
- NCT00002116
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Mount Zion Med Ctr / UCSF
🇺🇸San Francisco, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Univ of North Carolina Hosps
🇺🇸Chapel Hill, North Carolina, United States
Univ of Washington / Viral Disease Clinic
🇺🇸Seattle, Washington, United States
Park Plaza Hosp
🇺🇸Houston, Texas, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Univ of British Columbia / Univ Hosp
🇨🇦Vancouver, British Columbia, Canada