A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
1 other identifier
interventional
100
1 country
42
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 27, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483, United States
Florida Keys Memorial Hosp
Key West, Florida, 33040, United States
Med Service
Miami, Florida, 33125, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, 089030019, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Nassau County Med Ctr
East Meadow, New York, 11554, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Columbia Presbyterian Med Ctr
New York, New York, 100323784, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY / State Univ of New York
Syracuse, New York, 13210, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Wake Med Ctr / Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098, United States
Med Univ of South Carolina / UNC
Charleston, South Carolina, 29425, United States
Northwest Family Ctr at the Harbor View Med Ctr
Seattle, Washington, 98104, United States
Univ of Washington
Seattle, Washington, 981224304, United States
Related Publications (1)
Silva MG, Cruz ML, Lopes GB, Leite CG, Menezes JA. Neurosyphilis in HIV patients. Int Conf AIDS. 1996 Jul 7-12;11(2):280 (abstract no ThB4170)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hook EW III
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1996
Last Updated
October 27, 2021
Record last verified: 2021-10