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



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

For Condition: HIV Infections,Neurosyphilis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 100

Location and Contact Information:

Overall Study Official:
HookIII,  Study Chair, 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Northwest Family Ctr at the Harbor View Med Ctr
Seattle,  Washington,  98104
United States
 

Nassau County Med Ctr
East Meadow,  New York,  11554
United States
 

Yale Univ / New Haven
New Haven,  Connecticut,  065102483
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Thomas Jefferson Univ Hosp
Philadelphia,  Pennsylvania,  191075098
United States
 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  921036325
United States
 

Wake Med Ctr / Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Montefiore Med Ctr Adolescent AIDS Program
Bronx,  New York,  10467
United States
 

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10025
United States
 

Robert Wood Johnson Med School/UMDNJ
New Brunswick,  New Jersey,  089030019
United States
 

Miami Veterans Administration Med Ctr
Miami,  Florida,  33125
United States
 

San Francisco Veterans Administration Med Ctr
San Francisco,  California,  94121
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Harbor UCLA Med Ctr
Torrance,  California,  90502
United States
 

Florida Keys Memorial Hosp
Key West,  Florida,  33040
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  33136
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

Samaritan Village Inc / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  100323784
United States
 

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

SUNY / State Univ of New York
Syracuse,  New York,  13210
United States
 

Med Univ of South Carolina / UNC
Charleston,  South Carolina,  29425
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

SUNY / Health Sciences Ctr at Brooklyn
Brooklyn,  New York,  112032098
United States
 

North Central Bronx Hosp / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28203
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Med Service
Miami,  Florida,  33125
United States
 

Beth Israel Deaconess Med Ctr
Boston,  Massachusetts,  02215
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 


Additional Information:
Study ID Numbers:
  ACTG 145; 
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000648

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