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
2 other identifiers
interventional
30
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1995
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (9)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599, United States
Park Plaza Hosp
Houston, Texas, 77004, United States
Univ of Washington / Viral Disease Clinic
Seattle, Washington, 98122, United States
Univ of British Columbia / Univ Hosp
Vancouver, British Columbia, Canada
Related Publications (1)
Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5.
PMID: 11364104BACKGROUND