A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00000648 |
|
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : October 27, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Neurosyphilis | Drug: Penicillin G potassium Drug: Ceftriaxone sodium | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 100 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals |
| Actual Study Completion Date : | February 1996 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000648
Show 42 study locations
| Study Chair: | Hook EW III |
| ClinicalTrials.gov Identifier: | NCT00000648 |
| Other Study ID Numbers: |
ACTG 145 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | October 27, 2021 |
| Last Verified: | October 2021 |
|
Penicillin G Neurosyphilis Drug Evaluation |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Ceftriaxone |
|
HIV Seropositivity Neurosyphilis HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Central Nervous System Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Syphilis Treponemal Infections Spirochaetales Infections Gram-Negative Bacterial Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Ceftriaxone Penicillins Penicillin G Penicillin G Benzathine Penicillin G Procaine Anti-Bacterial Agents |