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Trial NCT00000635

Resource URI: http://static.linkedct.org/resource/trials/NCT00000635
PropertyValue
linkedct:brief_title Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/3124>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:condition <http://static.linkedct.org/resource/condition/5936>
linkedct:criteria Inclusion Criteria Concurrent Medication: Included: - All medications deemed essential for best patient care, including zidovudine (AZT), Pneumocystis carinii pneumonia (PCP) prophylaxis, and acute or maintenance therapies for other opportunistic infections. Patients must have the following: - HIV infection or diagnosis of AIDS. - Mucocutaneous Herpes simplex virus infection. - Ability to give informed consent. Allowed: - Patients may be co-enrolled in other ACTG studies except for those in which treatments are expected to generate neutropenia. Subjects aged 13 - 17 may be enrolled with appropriate consent from parent or guardian. Exclusion Criteria Concurrent Medication: Excluded: - Acyclovir, ganciclovir, foscarnet, vidarabine or other investigational drugs with potential anti-Herpes simplex virus activity. Patients with the following are excluded: - Previous hypersensitivity reaction to trifluridine, polymyxin B or bacitracin. Prior Medication: Excluded: - Immunomodulators, lymphocyte replacement therapy or biologic response modifiers within 14 days prior to study entry.
linkedct:description HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir. Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine. Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion. Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine. Lesions are covered by a nonabsorbent dressing. Medication is applied every 8 hours.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 13 Years
linkedct:enrollment 25 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000635
rdfs:label Trial NCT00000635
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:location <http://static.linkedct.org/resource/location/153656>
linkedct:location <http://static.linkedct.org/resource/location/155963>
linkedct:location <http://static.linkedct.org/resource/location/163631>
linkedct:location <http://static.linkedct.org/resource/location/168367>
linkedct:location <http://static.linkedct.org/resource/location/177831>
linkedct:location <http://static.linkedct.org/resource/location/205892>
linkedct:nct_id NCT00000635
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
linkedct:org_study_id ACTG 172
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/32874>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000635>
linkedct:phase N/A
linkedct:reference <http://static.linkedct.org/resource/reference/1924>
linkedct:reference <http://static.linkedct.org/resource/reference/50097>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label, Safety Study
linkedct:study_type Interventional
linkedct:summary To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
rdf:type linkedct:trials
linkedct:verification_date October 2003