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A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Neurosyphilis

Intervention: Penicillin G potassium (Drug); Ceftriaxone sodium (Drug)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Hook EW III, Study Chair

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.

Clinical Details

Official title: A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals

Study design: Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Detailed 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.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States

San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States

Harbor UCLA Med Ctr, Torrance, California 90502, United States

Yale Univ / New Haven, New Haven, Connecticut 065102483, United States

Florida Keys Memorial Hosp, Key West, Florida 33040, United States

Med Service, Miami, Florida 33125, United States

Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States

Univ of Miami School of Medicine, Miami, Florida 33136, United States

Northwestern Univ Med School, Chicago, Illinois 60611, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States

Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana 46202, United States

Johns Hopkins Hosp, Baltimore, Maryland 21287, United States

Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States

Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States

Robert Wood Johnson Med School/UMDNJ, New Brunswick, New Jersey 089030019, United States

Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States

Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States

Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States

Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York 10467, United States

Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York 10467, United States

North Central Bronx Hosp / Bronx Municipal Hosp, Bronx, New York 10467, United States

Samaritan Village Inc / Bronx Municipal Hosp, Bronx, New York 10461, United States

SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 112032098, United States

SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States

Nassau County Med Ctr, East Meadow, New York 11554, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Columbia Presbyterian Med Ctr, New York, New York 100323784, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States

Univ of Rochester Medical Center, Rochester, New York 14642, United States

SUNY / State Univ of New York, Syracuse, New York 13210, United States

Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States

Wake Med Ctr / Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States

Carolinas Med Ctr, Charlotte, North Carolina 28203, United States

Univ of Cincinnati, Cincinnati, Ohio 452670405, United States

Thomas Jefferson Univ Hosp, Philadelphia, Pennsylvania 191075098, United States

Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania 19104, United States

Med Univ of South Carolina / UNC, Charleston, South Carolina 29425, United States

Northwest Family Ctr at the Harbor View Med Ctr, Seattle, Washington 98104, United States

Univ of Washington, Seattle, Washington 981224304, United States

Additional Information

Related publications:

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)


Last updated: October 24, 2012

Page last updated: August 23, 2015

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