Completed
A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-27
100
Participants Needed
42
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 42 locations
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
2
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
3
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Status Unknown
4
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
5
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
Status Unknown
6
Florida Keys Memorial Hosp
Key West, Florida, United States, 33040
Status Unknown
7
Med Service
Miami, Florida, United States, 33125
Status Unknown
8
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
Status Unknown
9
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Status Unknown
10
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
11
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
12
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
13
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
14
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
15
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Status Unknown
16
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
17
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, United States, 089030019
Status Unknown
18
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Status Unknown
19
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
20
Nassau County Med Ctr
East Meadow, New York, United States, 11554
Status Unknown
21
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
22
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Status Unknown
23
Columbia Presbyterian Med Ctr
New York, New York, United States, 100323784
Status Unknown
24
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
25
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Status Unknown
26
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
27
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
28
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
29
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
30
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10465
Status Unknown
31
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
32
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States, 10467
Status Unknown
33
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
34
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
35
Wake Med Ctr / Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
36
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28203
Status Unknown
37
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
38
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
39
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
Status Unknown
40
Med Univ of South Carolina / UNC
Charleston, South Carolina, United States, 29425
Status Unknown
41
Northwest Family Ctr at the Harbor View Med Ctr
Seattle, Washington, United States, 98104
Status Unknown
42
Univ of Washington
Seattle, Washington, United States, 981224304
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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