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

Completed · Not applicable

Conditions studied: HIV Infections, Neurosyphilis

In brief

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.

Key facts

Study ID

NCT00000648

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Expected to finish

1996-02-01

Last updated by the study team

2021-10-27

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, 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
• Harbor UCLA Med Ctr — Torrance, California, United States
• Yale Univ / New Haven — New Haven, Connecticut, 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
• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Robert Wood Johnson Med School/UMDNJ — New Brunswick, New Jersey, 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
• Nassau County Med Ctr — East Meadow, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• SUNY / State Univ of New York — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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