Trial · NCT03637660
Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
NCT03637660, Phase 4, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-12-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection. Trials, record NCT03637660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03637660
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
- NCT number
- NCT03637660
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 249 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Syphilis
- Interventions
- Benzathine Penicillin
- First posted
- 2018-08-20
- Last updated
- 2025-01-14
- Results first posted
- 2023-12-26
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With a Serological Response by Month 6. | Day 1 to Day 180 | 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: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion). |
| Secondary | Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Gender identity, sexual orientation, sexual partner, sex history in last 60 days |
| Secondary | Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Sex history in last 60 days |
| Secondary | Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Highest level of education completed, stage of syphilis, prior syphilis history |
| Secondary | Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire | Day 1 | Years of formal education |
| Secondary | Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Day 1 | Sex, Ethnicity, Race |
| Secondary | Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Day 1 | Age |
| Secondary | The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows | Through Month 12 | 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. |
| Secondary | The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations | Day 1 through Day 2 | 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. |
| Secondary | Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection | Day 1 to Day 180 | 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: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion). Serological response to therapy by Month 6 was examined among participants with and without HIV infection, |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With a Serological Response by Month 6. | Day 1 to Day 180 | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | 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. | days | MEAN |
| SECONDARY | Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Day 1 | 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. | count of partners | MEAN |
| SECONDARY | Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire | Day 1 | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire | Day 1 | 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. | years | MEAN |
| SECONDARY | Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Day 1 | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire | Day 1 | 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. | years | MEAN |
| SECONDARY | The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows | Through Month 12 | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations | Day 1 through Day 2 | The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group1,335
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With a Serological Response by Month 6. | One Dose BPG 2.4 MU | 94 | Participants | ||
| The Number of Participants With a Serological Response by Month 6. | Three Doses BPG 2.4 MU | 87 | Participants | ||
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | One Dose BPG 2.4 MU | Gender Identity : Man / HIV-infected | 67 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Three Doses BPG 2.4 MU | Gender Identity : Man / HIV-infected | 81 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | One Dose BPG 2.4 MU | Gender Identity : Man / Non HIV-infected | 46 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Three Doses BPG 2.4 MU | Gender Identity : Man / Non HIV-infected | 37 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | One Dose BPG 2.4 MU | Gender Identity : Man / Unknown HIV status | 3 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Three Doses BPG 2.4 MU | Gender Identity : Man / Unknown HIV status | 2 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | One Dose BPG 2.4 MU | Gender Identity : Woman / HIV-infected | 2 | Participants | |
| Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire | Three Doses BPG 2.4 MU | Gender Identity : Woman / HIV-infected | 0 | Participants |
1 to 10 of 1,335Source ClinicalTrials.gov
See all 1,335 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | One Dose BPG 2.4 MU | 124 | |
| Overall Study | STARTED | Three Doses BPG 2.4 MU | 125 | |
| Overall Study | COMPLETED | One Dose BPG 2.4 MU | 82 | |
| Overall Study | COMPLETED | Three Doses BPG 2.4 MU | 82 | |
| Overall Study | NOT COMPLETED | One Dose BPG 2.4 MU | 42 | |
| Overall Study | NOT COMPLETED | Three Doses BPG 2.4 MU | 43 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | One Dose BPG 2.4 MU | 0 | 124 | 0 |
| other | Nausea | Gastrointestinal disorders | Three Doses BPG 2.4 MU | 8 | 125 | 8 |
| other | Asthenia | General disorders | One Dose BPG 2.4 MU | 9 | 124 | 9 |
| other | Asthenia | General disorders | Three Doses BPG 2.4 MU | 14 | 125 | 14 |
| other | Chills | General disorders | One Dose BPG 2.4 MU | 11 | 124 | 11 |
| other | Chills | General disorders | Three Doses BPG 2.4 MU | 16 | 125 | 16 |
| other | Injection Site Induration | General disorders | One Dose BPG 2.4 MU | 7 | 124 | 7 |
| other | Injection Site Induration | General disorders | Three Doses BPG 2.4 MU | 17 | 125 | 17 |
| other | Injection Site Pain | General disorders | One Dose BPG 2.4 MU | 94 | 124 | 94 |
| other | Injection Site Pain | General disorders | Three Doses BPG 2.4 MU | 106 | 125 | 106 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | One Dose BPG 2.4 MU | 0 | 124 |
| Total, all-cause mortality | Three Doses BPG 2.4 MU | 0 | 125 |
| Total, other adverse events | One Dose BPG 2.4 MU | 98 | 124 |
| Total, other adverse events | Three Doses BPG 2.4 MU | 109 | 125 |
| Total, serious adverse events | One Dose BPG 2.4 MU | 1 | 124 |
| Total, serious adverse events | Three Doses BPG 2.4 MU | 2 | 125 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| One Dose BPG 2.4 MU vs Three Doses BPG 2.4 MU: The Number of Participants With a Serological Response by Month 6. | Trial comparisons |
| One Dose BPG 2.4 MU vs Three Doses BPG 2.4 MU: The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows | Trial comparisons |
One Dose BPG 2.4 MU vs Three Doses BPG 2.4 MU: 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. | Trial comparisons |
| One Dose BPG 2.4 MU vs Three Doses BPG 2.4 MU: The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations | Trial comparisons |
| One Dose BPG 2.4 MU vs Three Doses BPG 2.4 MU: deaths from any cause | Trial comparisons |
| One Dose BPG 2.4 MU vs Three Doses BPG 2.4 MU: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03637660
GET https://conductscience.org/api/trials/v1/NCT03637660/registered?page=2