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

Not Applicable

Completed

• Conditions: Neurosyphilis; HIV Infections

• Registration Number: NCT00000648
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Completion: 1996-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (42)

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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

Harbor UCLA Med Ctr; 🇺🇸 Torrance, California, United States

Yale Univ / New Haven; 🇺🇸 New Haven, Connecticut, 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

Northwestern Univ Med School; 🇺🇸 Chicago, Illinois, United States

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