MedPath

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

Not Applicable
Completed
Conditions
Neurosyphilis
HIV Infections
Registration Number
NCT00000648
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (42)

Northwestern Univ Med School

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Chicago, Illinois, United States

Rush Presbyterian - Saint Luke's Med Ctr

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Chicago, Illinois, United States

Beth Israel Deaconess Med Ctr

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Boston, Massachusetts, United States

Harbor UCLA Med Ctr

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Torrance, California, United States

Florida Keys Memorial Hosp

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Key West, Florida, United States

Johns Hopkins Hosp

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Baltimore, Maryland, United States

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp

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Bronx, New York, United States

Baystate Med Ctr of Springfield

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Springfield, Massachusetts, United States

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

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Bronx, New York, United States

Montefiore Family Health Ctr / Bronx Municipal Hosp

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Bronx, New York, United States

Samaritan Village Inc / Bronx Municipal Hosp

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Bronx, New York, United States

Jack Weiler Hosp / Bronx Municipal Hosp

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Bronx, New York, United States

North Central Bronx Hosp / Bronx Municipal Hosp

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Bronx, New York, United States

SUNY / Health Sciences Ctr at Brooklyn

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Brooklyn, New York, United States

Montefiore Med Ctr / Bronx Municipal Hosp

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Bronx, New York, United States

Nassau County Med Ctr

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East Meadow, New York, United States

Montefiore Med Ctr Adolescent AIDS Program

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Bronx, New York, United States

Bellevue Hosp / New York Univ Med Ctr

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New York, New York, United States

SUNY / Erie County Med Ctr at Buffalo

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Buffalo, New York, United States

Saint Luke's - Roosevelt Hosp Ctr

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New York, New York, United States

Univ of Rochester Medical Center

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Rochester, New York, United States

Columbia Presbyterian Med Ctr

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New York, New York, United States

Univ of North Carolina

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Chapel Hill, North Carolina, United States

SUNY / State Univ of New York

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Syracuse, New York, United States

Carolinas Med Ctr

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Charlotte, North Carolina, United States

Wake Med Ctr / Univ of North Carolina

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Chapel Hill, North Carolina, United States

Thomas Jefferson Univ Hosp

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Philadelphia, Pennsylvania, United States

Univ of Pennsylvania at Philadelphia

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Philadelphia, Pennsylvania, United States

Med Univ of South Carolina / UNC

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Charleston, South Carolina, United States

Med Service

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Miami, Florida, United States

Univ of California / San Diego Treatment Ctr

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San Diego, California, United States

Methodist Hosp of Indiana / Life Care Clinic

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Indianapolis, Indiana, United States

Miami Veterans Administration Med Ctr

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Miami, Florida, United States

Univ of Washington

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Seattle, Washington, United States

Univ of Miami School of Medicine

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Miami, Florida, United States

Indiana Univ Hosp

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Indianapolis, Indiana, United States

Univ of Cincinnati

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Cincinnati, Ohio, United States

Northwest Family Ctr at the Harbor View Med Ctr

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Seattle, Washington, United States

Univ of Alabama at Birmingham

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Birmingham, Alabama, United States

San Francisco Veterans Administration Med Ctr

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San Francisco, California, United States

Yale Univ / New Haven

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New Haven, Connecticut, United States

Robert Wood Johnson Med School/UMDNJ

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New Brunswick, New Jersey, United States

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