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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000648
Other study ID # ACTG 145
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Est. completion date February 1996

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 1996
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Penicillin G potassium

Ceftriaxone sodium


Locations

Country Name City State
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Beth Israel Deaconess Med Ctr Boston Massachusetts
United States Bronx Municipal Hosp Ctr/Jacobi Med Ctr Bronx New York
United States Jack Weiler Hosp / Bronx Municipal Hosp Bronx New York
United States Montefiore Drug Treatment Ctr / Bronx Municipal Hosp Bronx New York
United States Montefiore Family Health Ctr / Bronx Municipal Hosp Bronx New York
United States Montefiore Med Ctr / Bronx Municipal Hosp Bronx New York
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States North Central Bronx Hosp / Bronx Municipal Hosp Bronx New York
United States Samaritan Village Inc / Bronx Municipal Hosp Bronx New York
United States SUNY / Health Sciences Ctr at Brooklyn Brooklyn New York
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Wake Med Ctr / Univ of North Carolina Chapel Hill North Carolina
United States Med Univ of South Carolina / UNC Charleston South Carolina
United States Carolinas Med Ctr Charlotte North Carolina
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Nassau County Med Ctr East Meadow New York
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana
United States Florida Keys Memorial Hosp Key West Florida
United States Med Service Miami Florida
United States Miami Veterans Administration Med Ctr Miami Florida
United States Univ of Miami School of Medicine Miami Florida
United States Robert Wood Johnson Med School/UMDNJ New Brunswick New Jersey
United States Yale Univ / New Haven New Haven Connecticut
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Saint Luke's - Roosevelt Hosp Ctr New York New York
United States Thomas Jefferson Univ Hosp Philadelphia Pennsylvania
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of Rochester Medical Center Rochester New York
United States Univ of California / San Diego Treatment Ctr San Diego California
United States San Francisco Veterans Administration Med Ctr San Francisco California
United States Northwest Family Ctr at the Harbor View Med Ctr Seattle Washington
United States Univ of Washington Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States SUNY / State Univ of New York Syracuse New York
United States Harbor UCLA Med Ctr Torrance California

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Silva MG, Cruz ML, Lopes GB, Leite CG, Menezes JA. Neurosyphilis in HIV patients. Int Conf AIDS. 1996 Jul 7-12;11(2):280 (abstract no ThB4170)

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