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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000648 |
Purpose
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 | Intervention |
|---|---|
|
HIV Infections Neurosyphilis |
Drug: Penicillin G potassium Drug: Ceftriaxone sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment |
| Official Title: | A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals |
| Estimated 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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 42 Study Locations| Study Chair: | Hook EW III |
More Information
| Study ID Numbers: | ACTG 145 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000648 |
| Health Authority: | United States: Federal Government |
|
Penicillin G Neurosyphilis Drug Evaluation |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Ceftriaxone |
|
Bacterial Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Central Nervous System Diseases Procaine AIDS-Related Complex Ceftriaxone Immunologic Deficiency Syndromes Gram-Negative Bacterial Infections Virus Diseases |
Penicillin G, Procaine Penicillin G Penicillin G, Benzathine Central Nervous System Infections HIV Infections Neurosyphilis Sexually Transmitted Diseases Retroviridae Infections Syphilis |
|
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Nervous System Diseases Infection Pharmacologic Actions |
Anti-Bacterial Agents Treponemal Infections Spirochaetales Infections Therapeutic Uses Lentivirus Infections Central Nervous System Bacterial Infections |
