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Sponsored by: |
Gilead Sciences |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002116 |
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.
Condition | Intervention | Phase |
---|---|---|
Herpes Simplex HIV Infections |
Drug: Cidofovir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 30 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
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:
Prior Medication:
Excluded within 14 days prior to study entry:
Excluded within 4 weeks prior to study entry:
Required:
Substance abuse.
United States, California | |
Mount Zion Med Ctr / UCSF | |
San Francisco, California, United States, 94115 | |
UCSF - San Francisco Gen Hosp | |
San Francisco, California, United States, 94110 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21205 | |
United States, North Carolina | |
Univ of North Carolina Hosps | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Texas | |
Park Plaza Hosp | |
Houston, Texas, United States, 77004 | |
United States, Washington | |
Univ of Washington / Viral Disease Clinic | |
Seattle, Washington, United States, 98122 | |
Canada, British Columbia | |
Univ of British Columbia / Univ Hosp | |
Vancouver, British Columbia, Canada |
Study ID Numbers: | 218A, GS-93-301 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002116 |
Health Authority: | United States: Food and Drug Administration |
Herpes Simplex Acquired Immunodeficiency Syndrome Antiviral Agents cidofovir |
Herpes Simplex Cidofovir Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Skin Diseases, Infectious HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Infection |
Antiviral Agents Pharmacologic Actions Skin Diseases, Viral Anti-Retroviral Agents Radiation-Sensitizing Agents Therapeutic Uses Lentivirus Infections |