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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penicillin G potassium | Drug | |||
| Ceftriaxone sodium | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Unwilling or unable to comply with follow-up schedule, including repeat lumbar punctures.
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| Name | Affiliation | Role |
|---|---|---|
| Hook EW III | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Univ of California / San Diego Treatment Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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) |
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| 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 |
| Yale Univ / New Haven | New Haven | Connecticut | 065102483 | United States |
| Florida Keys Memorial Hosp | Key West | Florida | 33040 | United States |
| Med Service | Miami | Florida | 33125 | United States |
| Miami Veterans Administration Med Ctr | Miami | Florida | 33125 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | United States |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | United States |
| Methodist Hosp of Indiana / Life Care Clinic | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | United States |
| Robert Wood Johnson Med School/UMDNJ | New Brunswick | New Jersey | 089030019 | United States |
| SUNY / Health Sciences Ctr at Brooklyn | Brooklyn | New York | 112032098 | United States |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | United States |
| Nassau County Med Ctr | East Meadow | New York | 11554 | United States |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | United States |
| Saint Luke's - Roosevelt Hosp Ctr | New York | New York | 10025 | United States |
| Columbia Presbyterian Med Ctr | New York | New York | 100323784 | United States |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | United States |
| SUNY / State Univ of New York | Syracuse | New York | 13210 | United States |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | United States |
| Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | United States |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | United States |
| Samaritan Village Inc / Bronx Municipal Hosp | The Bronx | New York | 10461 | United States |
| Jack Weiler Hosp / Bronx Municipal Hosp | The Bronx | New York | 10465 | United States |
| Montefiore Med Ctr / Bronx Municipal Hosp | The Bronx | New York | 10467 | United States |
| Montefiore Med Ctr Adolescent AIDS Program | The Bronx | New York | 10467 | United States |
| North Central Bronx Hosp / Bronx Municipal Hosp | The Bronx | New York | 10467 | United States |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | United States |
| 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 Cincinnati | Cincinnati | Ohio | 452670405 | United States |
| Univ of Pennsylvania at Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | United States |
| Med Univ of South Carolina / UNC | Charleston | South Carolina | 29425 | United States |
| Northwest Family Ctr at the Harbor View Med Ctr | Seattle | Washington | 98104 | United States |
| Univ of Washington | Seattle | Washington | 981224304 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D009494 | Neurosyphilis |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000386 | AIDS-Related Complex |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D013587 | Syphilis |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
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