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

NCT00000648

CompletedNA

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: HIV Infections, Neurosyphilis

Interventions: Penicillin G potassium, Ceftriaxone sodium

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (42)

Birmingham, Alabama, United States
San Diego, California, United States
San Francisco, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
Key West, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
New Brunswick, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
East Meadow, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
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