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

Primary Purpose

HIV Infections, Neurosyphilis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penicillin G potassium
Ceftriaxone sodium
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Penicillin G, Neurosyphilis, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Ceftriaxone

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Univ of California / San Diego Treatment Ctr
  • San Francisco Veterans Administration Med Ctr
  • Harbor UCLA Med Ctr
  • Yale Univ / New Haven
  • Florida Keys Memorial Hosp
  • Med Service
  • Miami Veterans Administration Med Ctr
  • Univ of Miami School of Medicine
  • Northwestern Univ Med School
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Indiana Univ Hosp
  • Methodist Hosp of Indiana / Life Care Clinic
  • Johns Hopkins Hosp
  • Beth Israel Deaconess Med Ctr
  • Baystate Med Ctr of Springfield
  • Robert Wood Johnson Med School/UMDNJ
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  • Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
  • Montefiore Family Health Ctr / Bronx Municipal Hosp
  • Samaritan Village Inc / Bronx Municipal Hosp
  • Jack Weiler Hosp / Bronx Municipal Hosp
  • Montefiore Med Ctr / Bronx Municipal Hosp
  • Montefiore Med Ctr Adolescent AIDS Program
  • North Central Bronx Hosp / Bronx Municipal Hosp
  • SUNY / Health Sciences Ctr at Brooklyn
  • SUNY / Erie County Med Ctr at Buffalo
  • Nassau County Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Columbia Presbyterian Med Ctr
  • Univ of Rochester Medical Center
  • SUNY / State Univ of New York
  • Univ of North Carolina
  • Wake Med Ctr / Univ of North Carolina
  • Carolinas Med Ctr
  • Univ of Cincinnati
  • Univ of Pennsylvania at Philadelphia
  • Thomas Jefferson Univ Hosp
  • Med Univ of South Carolina / UNC
  • Northwest Family Ctr at the Harbor View Med Ctr
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00000648
Brief Title
A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
Official Title
A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1996 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.
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 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 treatment. Patients receiving penicillin G are hospitalized while receiving the penicillin. Patients receiving ceftriaxone are treated on an inpatient basis for at least the first three days and may then be discharged to receive outpatient treatment. During treatment, patients are permitted to take antiretroviral drugs or other drugs for opportunistic infections except for drugs that are antisyphilitic. Lumbar punctures will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Neurosyphilis
Keywords
Penicillin G, Neurosyphilis, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Ceftriaxone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Penicillin G potassium
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hook EW III
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale Univ / New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
065102483
Country
United States
Facility Name
Florida Keys Memorial Hosp
City
Key West
State/Province
Florida
ZIP/Postal Code
33040
Country
United States
Facility Name
Med Service
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Methodist Hosp of Indiana / Life Care Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Robert Wood Johnson Med School/UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Family Health Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Samaritan Village Inc / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jack Weiler Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Montefiore Med Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Central Bronx Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112032098
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Nassau County Med Ctr
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
100323784
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY / State Univ of New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Wake Med Ctr / Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ of Pennsylvania at Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191075098
Country
United States
Facility Name
Med Univ of South Carolina / UNC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Northwest Family Ctr at the Harbor View Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981224304
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Learn more about this trial

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

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