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.

Condition	Treatment or Intervention
HIV Infections Neurosyphilis	Drug: Penicillin G potassium  Drug: Ceftriaxone sodium

Further Study Details: 

Expected Total Enrollment:  100

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
California
      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
Connecticut
      Yale Univ / New Haven, New Haven,  Connecticut,  065102483,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
      Med Service, Miami,  Florida,  33125,  United States
      Miami Veterans Administration Med Ctr, Miami,  Florida,  33125,  United States
      Florida Keys Memorial Hosp, Key West,  Florida,  33040,  United States
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States
      Methodist Hosp of Indiana / Life Care Clinic, Indianapolis,  Indiana,  46202,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
Massachusetts
      Beth Israel Deaconess Med Ctr, Boston,  Massachusetts,  02215,  United States
      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States
New Jersey
      Robert Wood Johnson Med School/UMDNJ, New Brunswick,  New Jersey,  089030019,  United States
New York
      Montefiore Drug Treatment Ctr / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
      Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
      Samaritan Village Inc / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
      Nassau County Med Ctr, East Meadow,  New York,  11554,  United States
      SUNY / State Univ of New York, Syracuse,  New York,  13210,  United States
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Jack Weiler Hosp / Bronx Municipal Hosp, Bronx,  New York,  10465,  United States
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10025,  United States
      Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx,  New York,  10461,  United States
      Montefiore Med Ctr / Bronx Municipal Hosp, Bronx,  New York,  10467,  United States
      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States
      Montefiore Med Ctr Adolescent AIDS Program, Bronx,  New York,  10467,  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
      Columbia Presbyterian Med Ctr, New York,  New York,  100323784,  United States
North Carolina
      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 North Carolina, Chapel Hill,  North Carolina,  275997215,  United States
Ohio
      Univ of Cincinnati, Cincinnati,  Ohio,  452670405,  United States
Pennsylvania
      Univ of Pennsylvania at Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Thomas Jefferson Univ Hosp, Philadelphia,  Pennsylvania,  191075098,  United States
South Carolina
      Med Univ of South Carolina / UNC, Charleston,  South Carolina,  29425,  United States
Washington
      Univ of Washington, Seattle,  Washington,  981224304,  United States
      Northwest Family Ctr at the Harbor View Med Ctr, Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Hook EW III,  Study Chair

Study ID Numbers:  ACTG 145
Record last reviewed:  January 2003
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000648
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08