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NCT00000648

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

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1996-02-29

Brief Summary

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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

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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.

Conditions

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HIV Infections Neurosyphilis

Keywords

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Penicillin G Neurosyphilis Drug Evaluation Acquired Immunodeficiency Syndrome AIDS-Related Complex Ceftriaxone

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Penicillin G potassium

Intervention Type DRUG

Ceftriaxone sodium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Hook EW III

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States

Site Status

Harbor UCLA Med Ctr

Torrance, California, United States

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Yale Univ / New Haven

New Haven, Connecticut, United States

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Florida Keys Memorial Hosp

Key West, Florida, United States

Site Status

Med Service

Miami, Florida, United States

Site Status

Miami Veterans Administration Med Ctr

Miami, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Northwestern Univ Med School

Chicago, Illinois, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Site Status

Baystate Med Ctr of Springfield

Springfield, Massachusetts, United States

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Robert Wood Johnson Med School/UMDNJ

New Brunswick, New Jersey, United States

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SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, United States

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SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States

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Nassau County Med Ctr

East Meadow, New York, United States

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Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

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Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

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Columbia Presbyterian Med Ctr

New York, New York, United States

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Univ of Rochester Medical Center

Rochester, New York, United States

Site Status