HIV InfectionsNCT00000648
A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
A study testing Penicillin G potassium and Ceftriaxone sodium in people with HIV Infections and Neurosyphilis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Neurosyphilis
- What is being tested?
- Penicillin G potassium and Ceftriaxone sodium
- How many people
- 100 participants
- Where
- 42 sitesUnited States
- Study dates
- Start not givento Feb 1996
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- Have HIV infection.
- Have presumable or documented neurosyphilis.
- Be capable of giving informed consent.
- Have life expectancy of at least 52 weeks.
Who cannot join
- 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:
Show all 14Show fewer
- 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.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Wake Med Ctr / Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Med Univ of South Carolina / UNC
Charleston, South Carolina, 29425
Carolinas Med Ctr
Charlotte, North Carolina, 28203
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Nassau County Med Ctr
East Meadow, New York, 11554
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Florida Keys Memorial Hosp
Key West, Florida, 33040
Med Service
Miami, Florida, 33125
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Univ of Miami School of Medicine
Miami, Florida, 33136
Robert Wood Johnson Med School/UMDNJ
New Brunswick, New Jersey, 089030019
Yale Univ / New Haven
New Haven, Connecticut, 065102483
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Columbia Presbyterian Med Ctr
New York, New York, 100323784
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Northwest Family Ctr at the Harbor View Med Ctr
Seattle, Washington, 98104
Univ of Washington
Seattle, Washington, 981224304
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
SUNY / State Univ of New York
Syracuse, New York, 13210
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, 10461
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, 10467
Harbor UCLA Med Ctr
Torrance, California, 90502
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Neurosyphilis
- Being tested
- Penicillin G potassium, Ceftriaxone sodium
- Keywords
- Penicillin G, Neurosyphilis, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Ceftriaxone
- Medical subject headings
- HIV Infections, Neurosyphilis, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin G potassiumDrug
Ceftriaxone sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionFeb 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Investigators
- Hook EW III, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000648
- Sponsor's protocol ID
- ACTG 145
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 27 Oct 2021
- Results posted
- No
Publications
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)
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
- ClinicalTrials.gov ID
- NCT00000648
- Acronym / sponsor ID
- ACTG 145
- Conditions
- HIV Infections, Neurosyphilis
- Keywords
- Penicillin G, Neurosyphilis, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Ceftriaxone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Study completion
- Feb 1996 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Have HIV infection.
- Have presumable or documented neurosyphilis.
Key exclusion criteria (14 listed)
- 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.
- Antitreponemal therapy (amoxicillin, doxycycline, tetracycline hydrochloride, erythromycin, procaine penicillin, any beta lactam, or chloramphenicol).
- 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).
- Treatment for syphilis within 1 year prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penicillin G potassium | Drug | – |
| Ceftriaxone sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- BackgroundSilva 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hook EW III study chair
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penicillin G potassium and Ceftriaxone sodium in people with HIV Infections and Neurosyphilis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.