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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on 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. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including 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. 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 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 30
Location and Contact Information:
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Washington / Viral Disease Clinic
Seattle, Washington, 98122
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599
United States
Park Plaza Hosp
Houston, Texas, 77004
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Univ of British Columbia / Univ Hosp
Vancouver, British Columbia,
Canada
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: 218A; GS-93-301
Study Start Date:
Record last reviewed: December 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002116
Other Herpes Simplex Studies:
1. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
2. Herpetic Eye Disease Study (HEDS) II
3. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
4. Cidofovir as a Treatment for Herpes Simplex in Patients with AIDS
5. 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
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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
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