Search / Trial NCT00000648

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Penicillin G Neurosyphilis Drug Evaluation Acquired Immunodeficiency Syndrome Aids Related Complex Ceftriaxone

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 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 treatmen...

Gender

All

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.

Attachments

readout_NCT00000648_2023-11-28.pdf

4.5 MB

NCT00000648_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

San Francisco, California, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Springfield, Massachusetts, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

New York, New York, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Torrance, California, United States

New Haven, Connecticut, United States

Miami, Florida, United States

Baltimore, Maryland, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

East Meadow, New York, United States

Syracuse, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Key West, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Boston, Massachusetts, United States

New Brunswick, New Jersey, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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