Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Hoffmann-La Roche

Conditions:

HIV Infections

Neurosyphilis

Eligibility:

All Genders

13+ years

Phase:

NA

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 sy...

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 cen...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1996

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00000648

End Date

February 1 1996

Last Update

October 27 2021

Active Locations (42)

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Page 1 of 11 (42 locations)

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

3

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States, 94121

4

Harbor UCLA Med Ctr

Torrance, California, United States, 90502