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Trial NCT00000648

Resource URI: http://static.linkedct.org/resource/trials/NCT00000648
PropertyValue
linkedct:brief_title A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/3513>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:condition <http://static.linkedct.org/resource/condition/8821>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral drugs. - Concurrent treatment for opportunistic infections with non-antisyphilitic drugs. - Metronidazole, aminoglycosides, trimethoprim / sulfamethoxazole (TMP / SMX), polymyxin, vancomycin, dapsone, pentamidine, acyclovir, antifungals, clindamycin, immunomodulators, and quinolones. Patients must: - Have HIV infection. - Have presumable or documented neurosyphilis. - Be capable of giving informed consent. - Have life expectancy of at least 52 weeks. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - History of penicillin or cephalosporin immediate hypersensitivity reaction characterized by angioneurotic edema, hyperemia, urticaria, bronchospasm, and/or anaphylaxis. - History of mucosal or blistering rash in response to related treatment. Concurrent Medication: Excluded: - Antitreponemal therapy (amoxicillin, doxycycline, tetracycline hydrochloride, erythromycin, procaine penicillin, any beta lactam, or chloramphenicol). Patients with the following are excluded: - Other etiology of cerebrospinal (CSF) abnormalities other than HIV and syphilis infection in patients who present with clinical symptoms (this is not required in asymptomatic patients). Prior Medication: Excluded: - Treatment for syphilis within 1 year prior to study entry. - Antitreponemal therapy (amoxicillin, doxycycline, tetracycline hydrochloride, erythromycin, procaine penicillin, any beta lactam, or chloramphenicol) within 45 days prior to study entry. Unwilling or unable to comply with follow-up schedule, including repeat lumbar punctures.
linkedct:description Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV. HIV infected patients who are presumed to have neurosyphilis or have definitive neurosyphilis are treated for the neurosyphilis with either penicillin G or ceftriaxone. Patients are treated for 10 days and followed for 50 weeks after treatment. Patients receiving penicillin G are hospitalized while receiving the penicillin. Patients receiving ceftriaxone are treated on an inpatient basis for at least the first three days and may then be discharged to receive outpatient treatment. During treatment, patients are permitted to take antiretroviral drugs or other drugs for opportunistic infections except for drugs that are antisyphilitic. Lumbar punctures will be performed.
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 100 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000648
rdfs:label Trial NCT00000648
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
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linkedct:nct_id NCT00000648
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
linkedct:org_study_id ACTG 145
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/22976>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000648>
linkedct:phase N/A
linkedct:reference <http://static.linkedct.org/resource/reference/3142>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
rdf:type linkedct:trials
linkedct:verification_date January 2003