HIV Infections Clinical Trial
Official title:
A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
NCT number | NCT00000648 |
Other study ID # | ACTG 145 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Est. completion date | February 1996 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 1996 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hosp | Baltimore | Maryland |
United States | Univ of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Med Ctr | Boston | Massachusetts |
United States | Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Bronx | New York |
United States | Jack Weiler Hosp / Bronx Municipal Hosp | Bronx | New York |
United States | Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | Bronx | New York |
United States | Montefiore Family Health Ctr / Bronx Municipal Hosp | Bronx | New York |
United States | Montefiore Med Ctr / Bronx Municipal Hosp | Bronx | New York |
United States | Montefiore Med Ctr Adolescent AIDS Program | Bronx | New York |
United States | North Central Bronx Hosp / Bronx Municipal Hosp | Bronx | New York |
United States | Samaritan Village Inc / Bronx Municipal Hosp | Bronx | New York |
United States | SUNY / Health Sciences Ctr at Brooklyn | Brooklyn | New York |
United States | SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York |
United States | Univ of North Carolina | Chapel Hill | North Carolina |
United States | Wake Med Ctr / Univ of North Carolina | Chapel Hill | North Carolina |
United States | Med Univ of South Carolina / UNC | Charleston | South Carolina |
United States | Carolinas Med Ctr | Charlotte | North Carolina |
United States | Northwestern Univ Med School | Chicago | Illinois |
United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
United States | Univ of Cincinnati | Cincinnati | Ohio |
United States | Nassau County Med Ctr | East Meadow | New York |
United States | Indiana Univ Hosp | Indianapolis | Indiana |
United States | Methodist Hosp of Indiana / Life Care Clinic | Indianapolis | Indiana |
United States | Florida Keys Memorial Hosp | Key West | Florida |
United States | Med Service | Miami | Florida |
United States | Miami Veterans Administration Med Ctr | Miami | Florida |
United States | Univ of Miami School of Medicine | Miami | Florida |
United States | Robert Wood Johnson Med School/UMDNJ | New Brunswick | New Jersey |
United States | Yale Univ / New Haven | New Haven | Connecticut |
United States | Bellevue Hosp / New York Univ Med Ctr | New York | New York |
United States | Columbia Presbyterian Med Ctr | New York | New York |
United States | Saint Luke's - Roosevelt Hosp Ctr | New York | New York |
United States | Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania |
United States | Univ of Pennsylvania at Philadelphia | Philadelphia | Pennsylvania |
United States | Univ of Rochester Medical Center | Rochester | New York |
United States | Univ of California / San Diego Treatment Ctr | San Diego | California |
United States | San Francisco Veterans Administration Med Ctr | San Francisco | California |
United States | Northwest Family Ctr at the Harbor View Med Ctr | Seattle | Washington |
United States | Univ of Washington | Seattle | Washington |
United States | Baystate Med Ctr of Springfield | Springfield | Massachusetts |
United States | SUNY / State Univ of New York | Syracuse | New York |
United States | Harbor UCLA Med Ctr | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Hoffmann-La Roche |
United States,
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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