Completed

Phase Not Applicable
Age: 13Years +
All Genders
ID00000648

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

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

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.

Not Eligible

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

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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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