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This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the US and last for 48 months with patient participation duration of 12 months. The primary objective is to compare the serological response to therapy in subjects with early (primary, secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million units (MU) once or weekly for three successive weeks.
This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the US and last for 48 months with patient participation duration of 12 months. The primary objective is to compare the serological response to therapy in subjects with early (primary, secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million units (MU) once or weekly for three successive weeks. The secondary objectives are: 1) to determine if the difference in response to therapy between treatment arms by Month 6 differs among subjects with or without HIV infection; 2) to determine the impact of multiple BPG injected doses on subject compliance with study product and adherence to the corresponding scheduled visits; 3) to determine the incidence and manifestations of the Jarisch-Herxheimer reaction among subjects treated for early syphilis with BPG; 4) to collect prospective data up to Month 12 on the serological response to therapy in subjects treated for early syphilis with either BPG regimen; 5) to compare epidemiological characteristics of early syphilis among subjects with or without HIV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly on Day 1, n=280 |
|
| 2 | Experimental | 2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly weekly for three successive weeks, n=280 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzathine Penicillin | Drug | BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With a Serological Response by Month 6. | Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:
| Day 1 to Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Gender identity, sexual orientation, sexual partner, sex history in last 60 days | Day 1 |
| Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire |
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Inclusion Criteria:
Subject is aged 18 years or older.
Subject has provided informed consent.
Subject has untreated primary*, secondary**, or early latent*** syphilis.
*Primary syphilis is characterized by the presence of an ulcerative lesion at a potential site of inoculation (while classically solitary, shallow, painless and with an indurated, clean base, primary lesions may be multiple, may vary considerably in appearance, and/or may not be painless) or by darkfield, acceptable polymerase chain reaction (PCR), or direct fluorescence antibody-T. pallidum (DFA-TP) positive ulcers.
**Secondary syphilis is characterized by classical palmar/plantar rash, condylomata lata, mucous patches, etc. or by darkfield, acceptable PCR, or DFA-TP positive lesions.
***Early latent syphilis is characterized by current reactive serologic tests for syphilis (STS) and a documented non-reactive STS, or documented sexual exposure to an individual known to have primary, secondary, or early latent syphilis diagnosed within the last 12 months.
Subject either has a newly reactive non-treponemal test (such as an RPR test) or a history of syphilis and a current increase in RPR titer of two or more dilutions (i.e., four-fold).
If subject is of childbearing potential, subject has a negative urine or serum pregnancy test.
Subject is willing to have an human immunodeficiency virus (HIV) test, participate in HIV counseling, and return to clinic for follow-up.
In the opinion of the investigator, subject is able and willing to comply with study procedures, including receipt of three Benzathine Penicillin G (BPG) injected doses if randomized to Arm 2.
If female, subject must be of non-childbearing potential* or must be using an acceptable method of birth control** to avoid becoming pregnant.
Non-childbearing potential is defined as being post-menopausal for at least 1 year, status after bilateral tubal ligation, or status after bilateral oophorectomy, or status after hysterectomy.
Subject must agree to avoid becoming pregnant by using one of the following acceptable methods of birth control for the entire duration of participation in the trial:
Exclusion Criteria:
Subject previously enrolled in this trial.
Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular syphilis.*
*e.g., eye pain/redness, recent ocular change, and/or changes in visual acuity
Subject has a known or suspected allergy or hypersensitivity to penicillin or other beta-lactam antibiotics.
Subject has a known or suspected sexually transmitted infection (STI) other than syphilis requiring treatment with a drug active against T. pallidum.
Subject has used antibiotics* active against T. pallidum in the preceding 30 days.
*Note: the use of antimicrobials known to NOT be effective against T. pallidum (e.g., quinolones, sulfonamides, trimethoprim, metronidazole, spectinomycin) will be allowed.
Subject has suspected or known ongoing drug use that might interfere with study participation and follow-up treatment.
Subject is breastfeeding.
Subject has used an investigational drug in the past 30 days that might interfere with safety or efficacy assessment.
*If the subject has used any investigational drugs in the past 30 days, contact the Principal Investigator, Division of Microbiology and Infectious Diseases (DMID) Clinical Project Manager, DMID Medical Officer, and FHI 360 to confirm eligibility.
Subject has any other condition that, in the opinion of the investigator, would interfere with participation in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine - Infectious Disease | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40902161 | Derived | Hook EW 3rd, Dionne JA, Workowski K, McNeil CJ, Taylor SN, Batteiger TA, Dombrowski JC, Mayer KH, Sena AC, Hamill MM, Wiesenfeld HC, Zhu C, Perlowski C, Mejia-Galvis JE, Newman LM. One Dose versus Three Doses of Benzathine Penicillin G in Early Syphilis. N Engl J Med. 2025 Sep 4;393(9):869-878. doi: 10.1056/NEJMoa2401802. | |
| 39946129 |
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Participants were aged 18 years or older with untreated early syphilis recruited from the communities at large around the ten clinical sites. Participants were enrolled between 31OCT2018 and 03MAR2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | One Dose BPG 2.4 MU | 2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly on Day 1 Benzathine Penicillin: BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock. |
| FG001 | Three Doses BPG 2.4 MU |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2020 | Jun 23, 2023 |
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Sex history in last 60 days |
| Day 1 |
| Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire | Highest level of education completed, stage of syphilis, prior syphilis history | Day 1 |
| Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire | Years of formal education | Day 1 |
| Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Sex, Ethnicity, Race | Day 1 |
| Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Age | Day 1 |
| The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows | Compliance with study product will be defined as the participant received all assigned doses within the assigned visit windows. A participant is not adherent to study product if they miss at least one dose or receive at least one dose out of the visit window. | Through Month 12 |
| The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations | Approximately 24 hours after Visit 1, participants were contacted and evaluated for symptoms of a JHR, which included fever, chills, myalgia, weakness, flushing, worsening of skin rash, tachycardia, heart palpitations, arthralgia, nausea, headache, and dizziness, including time of onset and time of resolution of each symptom reported. | Day 1 through Day 2 |
| Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection | Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:
Serological response to therapy by Month 6 was examined among participants with and without HIV infection, | Day 1 to Day 180 |
| Number of Participants With Serological Response (Defined as Either a 4-fold or Greater Decline in Rapid Plasma Regain (RPR) Titer Compared to Baseline or Being Rapid Plasma Regain -Negative [Seroreversion]) by Month 12. | Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 12 visit window) were evaluated:
| Through month 12 |
| Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection | Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:
Serological response to therapy by Month 12 was examined among participants with and without HIV infection, | Through month 12 |
| Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through week 1 |
| Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through week 2 |
| Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through month 1 |
| Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through month 3 |
| Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through month 6 |
| Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through month 9 |
| Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire | Sex history since last visit. | Through month 12 |
| Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through week 1 |
| Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through week 2 |
| Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through month 1 |
| Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through month 3 |
| Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through month 6 |
| Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through month 9 |
| Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire | Sex history since last visit | Through month 12 |
| Emory University Hospital Midtown - Emory Clinic Infectious Diseases |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Indiana University School of Medicine - Infectious Diseases | Indianapolis | Indiana | 46202 | United States |
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70119 | United States |
| Johns Hopkins Bayview Medical Center - Infectious Diseases | Baltimore | Maryland | 21224 | United States |
| Fenway Health - The Fenway Institute | Boston | Massachusetts | 02115 | United States |
| University of North Carolina School of Medicine - Center for Infectious Diseases | Durham | North Carolina | 27701-3720 | United States |
| Wake Forest Baptist Health - Infectious Diseases | Winston-Salem | North Carolina | 27157 | United States |
| Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Washington - Harborview Medical Center - Center for AIDS and STD | Seattle | Washington | 98104-2433 | United States |
| Dionne JA, Zhu C, Mejia-Galvis J, Workowski K, Batteiger TA, Dombrowski JC, Mayer KH, McNeil CJ, Sena AC, Taylor S, Wiesenfeld HC, Hamill MM, Perlowski C, Hook EW 3rd. Jarisch-Herxheimer Reaction After Benzathine Penicillin G Treatment in Adults With Early Syphilis: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459490. doi: 10.1001/jamanetworkopen.2024.59490. |
| 38124508 | Derived | Dionne JA, Giacani L, Tamhane A, Workowski K, Lieberman NAP, Greninger AL, Perlowski C, Newman L, Hook EW 3rd. Prevalence and Predictors of Oral Treponema pallidum Detection by Quantitative Polymerase Chain Reaction in Early Syphilis. J Infect Dis. 2024 Jun 14;229(6):1628-1636. doi: 10.1093/infdis/jiad582. |
| 35067599 | Derived | Dionne-Odom J, Workowski K, Perlowski C, Taylor SN, Mayer KH, McNeil CJ, Hamill MM, Dombrowski JC, Batteiger TA, Sena AC, Wiesenfeld HC, Newman L, Hook EW 3rd. Coinfection With Chlamydial and Gonorrheal Infection Among US Adults With Early Syphilis. Sex Transm Dis. 2022 Aug 1;49(8):e87-e89. doi: 10.1097/OLQ.0000000000001605. Epub 2022 Jan 24. |
2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly weekly for three successive weeks Benzathine Penicillin: BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | One Dose BPG 2.4 MU | 2.4 MU of BPG intramuscularly on Day 1 |
| BG001 | Three Doses BPG 2.4 MU | 2.4 MU of BPG intramuscularly weekly for three successive weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Highest Level of Education Completed | Count of Participants | Participants |
| ||||||||||||||||
| Stage of Syphilis | Syphilis Staging: Early latent - current reactive serologic tests for syphilis (STS) and a documented non-reactive STS, or documented sexual exposure to an individual known to have syphilis diagnosed within the last 12 months. Primary - presence of an ulcerative lesion at a potential site of inoculation or by darkfield, acceptable polymerase chain reaction, or direct fluorescence antibody-T. pallidum positive ulcers. Secondary - classical palmar/plantar rash, condylomata lata, mucous patches, etc. or by darkfield, acceptable PCR, or DFA-TP positive lesions. | Count of Participants | Participants |
| |||||||||||||||
| Prior Syphilis History | Count of Participants | Participants |
| ||||||||||||||||
| Years of Formal Education | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With a Serological Response by Month 6. | Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:
| The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Day 1 to Day 180 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Gender identity, sexual orientation, sexual partner, sex history in last 60 days | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Sex history in last 60 days | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. Participants contributing to this outcome measure include those who answered yes to either having intercourse in the past 60 days or reported being diagnosed with at least one STI in the past 60 days. | Posted | Mean | Standard Deviation | days | Day 1 |
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| Secondary | Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Sex history in last 60 days | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. Participants contributing to this outcome measure include those who answered yes to either having intercourse in the past 60 days or reported being diagnosed with at least one STI in the past 60 days. | Posted | Mean | Standard Deviation | count of partners | Day 1 |
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| Secondary | Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire | Highest level of education completed, stage of syphilis, prior syphilis history | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire | Years of formal education | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | years | Day 1 |
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| Secondary | Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Sex, Ethnicity, Race | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Age | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | years | Day 1 |
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| Secondary | The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows | Compliance with study product will be defined as the participant received all assigned doses within the assigned visit windows. A participant is not adherent to study product if they miss at least one dose or receive at least one dose out of the visit window. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through Month 12 |
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| Secondary | The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations | Approximately 24 hours after Visit 1, participants were contacted and evaluated for symptoms of a JHR, which included fever, chills, myalgia, weakness, flushing, worsening of skin rash, tachycardia, heart palpitations, arthralgia, nausea, headache, and dizziness, including time of onset and time of resolution of each symptom reported. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Day 1 through Day 2 |
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| Secondary | Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection | Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:
Serological response to therapy by Month 6 was examined among participants with and without HIV infection, | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Count of Participants | Participants | Day 1 to Day 180 |
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| Secondary | Number of Participants With Serological Response (Defined as Either a 4-fold or Greater Decline in Rapid Plasma Regain (RPR) Titer Compared to Baseline or Being Rapid Plasma Regain -Negative [Seroreversion]) by Month 12. | Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 12 visit window) were evaluated:
| The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 12 |
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| Secondary | Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection | Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated:
Serological response to therapy by Month 12 was examined among participants with and without HIV infection, | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 12 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through week 1 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through week 2 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 1 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 3 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 6 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 9 |
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| Secondary | Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire | Sex history since last visit. | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Posted | Count of Participants | Participants | Through month 12 |
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| Secondary | Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through week 1 |
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| Secondary | Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through week 2 |
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| Secondary | Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through month 1 |
|
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| Secondary | Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through month 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through month 6 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through month 9 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire | Sex history since last visit | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. | Posted | Mean | Standard Deviation | count of partners | Through month 12 |
|
|
Day 1 through Day 31
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | One Dose BPG 2.4 MU | 2.4 MU of BPG intramuscularly on Day 1 | 0 | 124 | 1 | 124 | 98 | 124 |
| EG001 | Three Doses BPG 2.4 MU | 2.4 MU of BPG intramuscularly weekly for three successive weeks | 0 | 125 | 2 | 125 | 109 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctocolitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Substance Induced Psychotic Disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Right Sided Facial Weakness | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Injection Site Induration | General disorders | Systematic Assessment |
| ||
| Injection Site Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward W. Hook, III | University of Alabama at Birmingham | 205-932-4204 | ehooks@uabmc.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2022 | Jun 23, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2019 | Jun 13, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010401 | Penicillin G Benzathine |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Completed High School |
|
| Completed Junior College |
|
| Completed College (Undergraduate Degree) |
|
| Completed Graduate Degree |
|
| Primary Syphilis |
|
| Secondary Syphilis |
|
| Missing 'Stage of Syphilis' |
|
The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin. |
| Non-Inferiority |
The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions. |
|
|
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| Units | Counts |
|---|
| Participants |
|
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|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| HIV-uninfected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Unknown HIV status |
|
| Non HIV-infected |
|
| Unknown HIV status |
|
| Unknown HIV status |
|