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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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