protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT05584657 | 5.2.2 | Preparation and Dispensing | 5.2.2 Preparation and Dispensing All kits of study drug will be provided to the study site by Iterum Therapeutics. Dispensing of study medication will be done and documented in accordance with the treatment schedule as outlined in the study protocol. Written dispensing instructions will be provided to each study site i... | [] |
NCT05584657 | 5.2.3 | Administration | 5.2.3 Administration Patients randomized to the sulopenem treatment group will take one sulopenem etzadroxil/probenecid tablet and one placebo capsule twice daily for 5 days and those randomized to the amoxicillin/clavulanate treatment group will take one over-encapsulated amoxicillin/clavulanate tablet and one placebo... | [
"Dosing with food:"
] |
NCT05584657 | 5.2.4 | Compliance | 5.2.4 Compliance All patients should be informed that compliance with taking all oral medication as instructed is imperative. Patients will be asked to bring all study medication containers (used and unused) to the next scheduled study visit for drug accountability. The total amount of oral dosing completed (determined... | [] |
NCT05584657 | 5.3 | Drug Storage and Drug Accountability | 5.3 Drug Storage and Drug Accountability The investigator, or an approved representative, e.g., pharmacist/designee, will ensure that all investigational products are stored in a secured area, under recommended storage conditions, and in accordance with applicable regulatory requirements. To ensure adequate records, th... | [] |
NCT05584657 | 5.4 | Concomitant Medication(s), Adjunctive Therapy, and Non-drug Therapy | 5.4 Concomitant Medication(s), Adjunctive Therapy, and Non-drug Therapy | [] |
NCT05584657 | 5.4.1 | Concomitant Medications | 5.4.1 Concomitant Medications Any medication taken by the patient during the study, other than study drug, is considered concomitant medication. All concomitant medications from Baseline (Day 1) through the Final Visit must be recorded in the patient's source record and on the Case Report Form (CRF). At each visit, the... | [] |
NCT05584657 | 5.4.2 | Adjunctive Systemic Antibiotics (Rescue Therapy) | 5.4.2 Adjunctive Systemic Antibiotics (Rescue Therapy) In general, adjunctive systemic antibiotics are not allowed for patients enrolled in the study. At any time during the study period, and at the discretion of the principal investigator (PI), additional antibiotics—oral or IV, as appropriate—can be prescribed as res... | [] |
NCT05584657 | 5.4.3 | Additional Non-Study Therapy Antibiotics | 5.4.3 Additional Non-Study Therapy Antibiotics Concomitant systemic antibacterials are prohibited during the study, up to the Day 28 (± 2 days) visit, with the following exceptions: - For Clostridioides difficile infections, metronidazole (IV or oral), vancomycin (oral or rectal), or fidaxomicin (oral) may be used in b... | [] |
NCT05584657 | 6 | STUDY PROCEDURES | 6 STUDY PROCEDURES | [] |
NCT05584657 | 6.1 | Screening (Day -1) - Within 24 Hours Prior to First Dose | 6.1 Screening (Day -1) - Within 24 Hours Prior to First Dose The investigator (or an appropriate delegate at the investigator site) will obtain written informed consent from each patient prior to the initiation of any study related activities. Urine samples, including results from urine tests, collected as part of rout... | [] |
NCT05584657 | 6.2 | Treatment Period | 6.2 Treatment Period For the study period described below, where multiple procedures are scheduled at the same time point(s) relative to dosing, the following chronology of events should be adhered to, where possible. • Blood pressure/pulse rate: obtain prior to blood specimen collection | [] |
NCT05584657 | 6.2.1 | Day 1 | 6.2.1 Day 1 - Review concomitant medications and adverse events if Day 1 visit not on same day as Screening/Day -1 visit - Confirm eligibility if Day 1 visit not on same day as Screening/Day -1 visit - Randomize patient - Provide patient daily dosing diary along with instructions on how to complete - Have patient compl... | [] |
NCT05584657 | 6.2.2 | Day 5 (+ 1 day) (End of Treatment/EOT) | 6.2.2 Day 5 (+ 1 day) (End of Treatment/EOT) - Targeted physical examination, if required, based on patient's symptoms (as determined by the investigator) Approved - Vital signs (temperature, blood pressure, pulse rate, respiratory rate) - Bank urine for retrospective assessments - Collect urine for urinalysis and urin... | [] |
NCT05584657 | 6.3 | Follow-up Period | 6.3 Follow-up Period | [] |
NCT05584657 | 6.3.1 | Day 12 (± 1 day) (Test of Cure/TOC) | 6.3.1 Day 12 (± 1 day) (Test of Cure/TOC) - Targeted physical examination, if required, based on patient's symptoms (as determined by the investigator) - Vital signs (temperature, blood pressure, pulse rate, respiratory rate) - Blood for laboratory testing (including hematology and chemistry studies) - Bank serum and u... | [] |
NCT05584657 | 6.3.2 | Day 28 (± 2 days) (Final Visit/FV) | 6.3.2 Day 28 (± 2 days) (Final Visit/FV) - Targeted physical examination, if required, based on patient's symptoms (as determined by the investigator) - Perform urine pregnancy test on women of child-bearing potential, including peri-menopausal women, and confirm negative result. Women of child-bearing potential and pe... | [] |
NCT05584657 | 6.4 | Premature Discontinuation | 6.4 Premature Discontinuation - Targeted physical examination, if required, based on patient's symptoms (as determined by the investigator) - Vital signs (temperature, blood pressure, pulse rate, respiratory rate) - Blood for laboratory testing including hematology and chemistry studies - Perform urine pregnancy test o... | [] |
NCT05584657 | 6.5 | Patient Withdrawal from Treatment or Study | 6.5 Patient Withdrawal from Treatment or Study Patients may withdraw from the study or study drug at any time at their own request, or they may be withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, or administrative reasons. If a patient does not return for a scheduled visit,... | [] |
NCT05584657 | 7 | ASSESSMENTS | 7 ASSESSMENTS | [] |
NCT05584657 | 7.1 | Safety | 7.1 Safety | [] |
NCT05584657 | 7.1.1 | Physical Examination | 7.1.1 Physical Examination A targeted physical examination will be performed at Baseline (including general appearance, examination of heart, lungs, abdomen, and extremities). A targeted physical exam may be conducted at any visit to address patient's symptoms if needed (as determined by the investigator). 7.1.2 Vital ... | [] |
NCT05584657 | 7.1.3 | Clinical Laboratory Assays | 7.1.3 Clinical Laboratory Assays The following laboratory parameters will be measured: - Hematology: Complete blood count (CBC), including white blood cell (WBC) and differential counts; at Baseline, Day 12 (± 1 day)/TOC or Premature Discontinuation - Serum Clinical Chemistry: AST, ALT, GGT, alkaline phosphatase, album... | [] |
NCT05584657 | 7.1.4 | Clinically Significant Laboratory Tests | 7.1.4 Clinically Significant Laboratory Tests Clinical laboratory tests may be repeated during the study if deemed necessary as part of routine practice based on investigator judgment. All clinically significant abnormal laboratory test results occurring during the study will be repeated at appropriate intervals until ... | [] |
NCT05584657 | 7.2 | Efficacy | 7.2 Efficacy | [] |
NCT05584657 | 7.2.1 | Overall Response | 7.2.1 Overall Response Overall Response (at a given Visit) is assessed using the definitions listed below: A patient will be defined as a success if the following criteria are met (programmatically, based on the data on the eCRF): - The patient is alive - The patient has received no rescue therapy for uUTI - If an anti... | [] |
NCT05584657 | 7.2.2 | Microbiologic | 7.2.2 Microbiologic | 7.2.2Microbiologic | | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05584657 | 7.2.3 | Patient-Determined Clinical Response | 7.2.3 Patient-Determined Clinical Response A patient will be defined as a clinical success if the following criteria are met (programmatically, based on the data on the eCRF): • The patient is alive - The patient has received no rescue therapy for uUTI - If an antibiotic active against the urinary tract pathogen is giv... | [] |
NCT05584657 | 7.2.4 | Investigator Assessment of Clinical Response | 7.2.4 Investigator Assessment of Clinical Response | dInvestigators will use the definitions below to document clinical response, irrespective ofmicrobiologic findings, at Day 5 (+ 1 day), Day 12 (± 1 day)/TOC, Day 28 (± 2 days), orPremature Discontinuation: | | | | | | | |----------------------------------------------... | [] |
NCT05584657 | 7.2.5 | Patient Symptom Assessment Questionnaire (PSAQ) | 7.2.5 Patient Symptom Assessment Questionnaire (PSAQ) Patients will score their UTI symptoms and record them on a Patient Symptom Assessment Questionnaire. PSAQ is administered on Day 1 (prior to first dose), Day 5 (+ 1 day)/EOT, Day 12 (± 1 day)/TOC, and Day 28 (± 2 days) visit, or Premature Discontinuation. In the ev... | [] |
NCT05584657 | 8 | ADVERSE EVENT REPORTING | 8 ADVERSE EVENT REPORTING | [] |
NCT05584657 | 8.1 | Adverse Events | 8.1 Adverse Events All observed or volunteered AEs regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported as described in the following sections. For all AEs, the investigator must pursue and obtain adequate information both to determine the outcome of the AE a... | [] |
NCT05584657 | 8.2 | Reporting Period | 8.2 Reporting Period Adverse events will be collected from the time that the patient provides informed consent through the Day 28 (± 2 days) (Final Visit). For SAEs, the reporting period to Iterum Therapeutics' designated pharmacovigilance provider (Medpace Safety) begins from the time that the patient provides informe... | [] |
NCT05584657 | 8.3 | Definition of an AE | 8.3 Definition of an AE An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device, unless the event is captured in the study endpoint, as defined below; the event need not necessarily have a causal relationship with the treatment or usage. An event would be co... | [] |
NCT05584657 | 8.4 | Abnormal Test Findings | 8.4 Abnormal Test Findings An abnormal objective test finding (e.g., an abnormal liver function test result) should be reported as an AE only if the following conditions apply: - Test result is associated with accompanying symptoms and/or signs, constituting a clinical syndrome (e.g., abnormal liver function test resul... | [] |
NCT05584657 | 8.5 | Serious Adverse Events (SAE) | 8.5 Serious Adverse Events (SAE) An SAE or serious adverse drug reaction is any untoward medical occurrence at any dose that: - Results in death; - Is life-threatening (immediate risk of death); - Requires inpatient hospitalization or prolongation of existing hospitalization; - Results in persistent or significant disa... | [] |
NCT05584657 | 8.6 | Hospitalization | 8.6 Hospitalization Adverse events associated with hospitalization or prolongations of hospitalization are considered serious. Admission also includes transfer within the hospital to an acute/intensive care unit (e.g., from the psychiatric wing to a medical floor, medical floor to a coronary care unit, neurological flo... | [] |
NCT05584657 | 8.7 | Severity Assessment | 8.7 Severity Assessment The investigator will use the adjectives MILD, MODERATE, or SEVERE to describe the maximum intensity of the AE. For purposes of consistency, these intensity grades are defined as follows: - MILD: Does not interfere with the patient's usual function. - MODERATE: Interferes to some extent with the... | [] |
NCT05584657 | 8.8 | Causality Assessment | 8.8 Causality Assessment The investigator's assessment of causality must be provided for all AEs (serious and nonserious); the investigator must record the causal relationship in the CRF, as appropriate, and report such an assessment in accordance with the serious adverse reporting requirements if applicable. An invest... | [] |
NCT05584657 | 8.9 | Exposure during Pregnancy | 8.9 Exposure during Pregnancy For investigational products and for marketed products, an exposure during pregnancy (also referred to as exposure in-utero [EIU]) occurs if: - 1. A female becomes, or is found to be, pregnant either while receiving or having been directly exposed to (e.g., environmental exposure) the inve... | [] |
NCT05584657 | 8.10 | Discontinuation from Study Drug Due to AEs (See also Patient Withdrawal, Section [6.5\)](#page-43-0) | 8.10 Discontinuation from Study Drug Due to AEs (See also Patient Withdrawal, Section [6.5\)](#page-43-0) Discontinuation from study drug due to an AE should be distinguished from discontinuation due to insufficient response, according to the definition of AE noted earlier, and recorded on the appropriate AE CRF page. ... | [] |
NCT05584657 | 8.11 | Eliciting AE Information | 8.11 Eliciting AE Information The investigator is to report all directly observed AEs and all AEs spontaneously reported by the study patient through the Final Visit. In addition, each study patient will be questioned about the occurrence of any AEs. | [] |
NCT05584657 | 8.12 | Reporting Requirements | 8.12 Reporting Requirements Each AE is to be assessed to determine if it meets the criteria for an SAE. If an SAE occurs that is considered by the investigator or the Sponsor to be at least possibly related to study drug, expedited reporting will follow local and international regulations, as appropriate. | [] |
NCT05584657 | 8.12.1 | SAE Reporting Requirements | 8.12.1 SAE Reporting Requirements If an SAE or exposure during pregnancy occurs, Iterum Therapeutics' designated pharmacovigilance provider (Medpace Safety) is to be notified within 24 hours of awareness of the event by the investigator electronically in the EDC system for the study. When the form in EDC is completed, ... | [] |
NCT05584657 | 8.12.2 | Non-SAE Reporting Requirements | 8.12.2 Non-SAE Reporting Requirements All AEs/SAEs will be reported on the AE page(s) of the CRF. Adverse events should be reported using concise medical terminology on the CRFs. | [] |
NCT05584657 | 8.12.3 | Sponsor Reporting Requirements to Regulatory Authorities | 8.12.3 Sponsor Reporting Requirements to Regulatory Authorities Adverse event reporting, including reporting of Suspected, Unexpected Serious Adverse Reactions (SUSARs), will be carried out in accordance with applicable local regulations. Death and life-threatening SUSARs are subject to expedited reporting within a 7-c... | [] |
NCT05584657 | 9 | DATA ANALYSIS/STATISTICAL METHODS | 9 DATA ANALYSIS/STATISTICAL METHODS | [] |
NCT05584657 | 9.1 | Sample Size Determination | 9.1 Sample Size Determination The study is designed to determine whether oral sulopenem is NI to oral amoxicillin/clavulanate for the outcome measure of overall success (combined clinical and microbiologic success) at Day 12 (± 1 day)/TOC in both the micro-MITT and micro-MITTS populations and whether oral sulopenem is ... | [] |
NCT05584657 | 9.2 | Definition of Analysis Populations | 9.2 Definition of Analysis Populations - 1. Intent-to-Treat (ITT): all randomized patients regardless of whether or not the patient received study drug - 2. Modified ITT (MITT): randomized patients who received at least a single dose of study medication. Patients will be analyzed according to the treatment to which the... | [] |
NCT05584657 | 9.3 | General Statistical Considerations | 9.3 General Statistical Considerations Descriptive statistics, including the numbers and percentages for categorical variables, and the numbers, means, standard deviations, medians, minimums, and maximums for continuous variables will be provided. All comparisons will be for the oral sulopenem treatment group and the a... | [] |
NCT05584657 | 9.4 | Patient Characteristics | 9.4 Patient Characteristics Enrollment, protocol deviations, discontinuations from the study drug and withdrawal from the study will be summarized by treatment group. Demographics (age, race, sex), medical history, baseline assessment of the symptoms of uUTI, microbiological assessment of the urine, and study drug admi... | [] |
NCT05584657 | 9.5 | Efficacy Analysis | 9.5 Efficacy Analysis For all efficacy analyses, patient data will be analyzed in the treatment group to which the patient was randomized. | [] |
NCT05584657 | 9.5.1 | Analysis of Primary Outcome Measure | 9.5.1 Analysis of Primary Outcome Measure The primary efficacy outcome is overall success (combined clinical and microbiologic success) at Day 12 (± 1 day)/TOC in the micro-MITT, micro-MITTS and micro-MITTR populations. Patients will be programmatically categorized as a success, failure, or indeterminate based on data ... | [] |
NCT05584657 | 9.5.2 | Additional Analyses of the Primary Efficacy Outcome | 9.5.2 Additional Analyses of the Primary Efficacy Outcome Sensitivity analyses of the primary outcome will be conducted in the micro-MITT, micro-MITTS and micro-MITTR populations. An analysis will consider all patients who have missing data for the primary outcome (i.e., an indeterminate response) as successes. A 2-sid... | [] |
NCT05584657 | 9.5.3 | Analysis of Secondary Efficacy Outcome Measure | 9.5.3 Analysis of Secondary Efficacy Outcome Measure The number and percentage of patients in each treatment group with a clinical response of success, failure and indeterminate at Day 12 (±1 day)/TOC will be presented for the MITT, micro-MITT, micro-MITTS, and micro-MITTR populations. The number and percentage of pati... | [] |
NCT05584657 | 9.5.4 | Analyses of Additional Efficacy Outcome Measures | 9.5.4 Analyses of Additional Efficacy Outcome Measures The number and percentage of patients in each treatment group with a clinical response of success, failure and indeterminate at Day 5 (+1 day), and Day 28 (±2 days) will be presented for the MITT, micro-MITT, micro-MITTS, and micro-MITTR populations. The number and... | [
"IT001-310 Protocol Amendment 1 12-5-2022 | VV-TMF-165994 | 1.0"
] |
NCT05584657 | 9.6 | Safety Analyses | 9.6 Safety Analyses Safety will be assessed through summaries of AEs, clinical laboratory tests, and vital signs. All safety analyses will be based on the Safety population. Patients who receive the wrong regimen of study drug for their entire course of treatment will be analyzed in the group based on the regimen recei... | [] |
NCT05584657 | 9.7 | Interim Analysis | 9.7 Interim Analysis To ensure that the point estimate of overall success (combined clinical and microbiologic success) used in the estimation of sample size, and the estimated eligibility rate, susceptibility rate, and rate of post-treatment asymptomatic bacteriuria is valid for this study, an interim analysis for sam... | [] |
NCT05584657 | 9.8 | Handling of Missing Data | 9.8 Handling of Missing Data Details of the handling of missing data will be provided in the SAP. For the primary and secondary efficacy analyses, if any data field needed to determine overall response (primary) and microbiological response (secondary) is missing at the Day 12 (±1 day)/TOC (primary) and Day 28 (±2 days... | [] |
NCT05584657 | 10 | QUALITY CONTROL AND QUALITY ASSURANCE | 10 QUALITY CONTROL AND QUALITY ASSURANCE During study conduct, Iterum or its agent will conduct periodic monitoring visits to ensure that the protocol and GCPs are being followed. The monitors may review source documents to confirm that the data recorded on CRFs are accurate. The investigator and institution will allow... | [] |
NCT05584657 | 11 | DATA HANDLING AND RECORD KEEPING | 11 DATA HANDLING AND RECORD KEEPING | [] |
NCT05584657 | 11.1 | Case Report Forms / Electronic Data Record | 11.1 Case Report Forms / Electronic Data Record As used in this protocol, the term CRF should be understood to refer to either a paper form or an electronic data record or both, depending on the data collection method used in this study. A CRF is required and should be completed for each included patient. The completed... | [] |
NCT05584657 | 11.2 | Record Retention | 11.2 Record Retention To enable evaluations and/or audits from regulatory authorities or Iterum, the investigator agrees to keep records, including the identity of all participating patients (sufficient information to link records, e.g., CRFs and hospital records), all original signed informed consent forms, copies of ... | [] |
NCT05584657 | 12 | ETHICS | 12 ETHICS | [] |
NCT05584657 | 12.1 | Institutional Review Board (IRB)/Independent Ethics Committee (IEC) | 12.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) It is the responsibility of the investigator to have prospective approval of the study protocol, protocol amendments, informed consent forms, and other relevant documents, e.g., recruitment advertisements, if applicable, from the IRB/IEC. All corr... | [] |
NCT05584657 | 12.2 | Ethical Conduct of the Study | 12.2 Ethical Conduct of the Study The study will be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Patients, adopted by the General Assembly of the World Medical Association (2013). In addition, the study will be conducted in accordance with the proto... | [] |
NCT05584657 | 12.3 | Patient Information and Consent | 12.3 Patient Information and Consent All parties will ensure protection of patient personal data and will not include patient names on any sponsor forms, reports, publications, or in any other disclosures, except where required by law. In case of data transfer, Iterum will maintain high standards of confidentiality and... | [] |
NCT05584657 | 12.4 | Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP | 12.4 Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP In the event of any prohibition or restriction imposed (i.e., clinical hold) by an applicable Competent Authority in any area of the world, or if the investigator becomes aware of any new information which might influence the evaluation of ... | [] |
NCT05584657 | 13 | DEFINITION OF END OF STUDY | 13 DEFINITION OF END OF STUDY | [] |
NCT05584657 | 13.1 | End of Study in all Participating Countries | 13.1 End of Study in all Participating Countries End of Study in all participating countries is defined as the last patient's Final Visit. | [] |
NCT05584657 | 14 | SPONSOR STUDY TERMINATION CRITERIA | 14 SPONSOR STUDY TERMINATION CRITERIA Premature termination of this study may occur because of a regulatory authority decision, change in opinion of the IRB/IEC, drug safety problems, or at the discretion of Iterum. In addition, Iterum retains the right to discontinue development of sulopenem at any time. If a study is... | [] |
NCT05584657 | 15 | PUBLICATION OF STUDY RESULTS | 15 PUBLICATION OF STUDY RESULTS Publication of study results is outlined in the Clinical Study Agreement. | [] |
NCT05584657 | 15.1 | Communication of Results by Iterum | 15.1 Communication of Results by Iterum Iterum fulfills its commitment to publicly disclose the results of studies through registration and posting of the results of this study on clinicaltrials.gov and EudraCT (eudract.ema.europa.eu) as applicable. | [] |
NCT05584657 | 15.2 | Publications by Investigators | 15.2 Publications by Investigators Iterum has no objection to publication by the Investigator of any information collected or generated by the Investigator, whether or not the results are favorable to the Investigational Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected ... | [
"IT001-310 Protocol Amendment 1 12-5-2022 | VV-TMF-165994 | 1.0"
] |
NCT05584657 | 16 | REFERENCE LIST | 16 REFERENCE LIST Banerjee R and Johnson JR. A New Clone Sweeps Clean: the Enigmatic Emergence of Escherichia coli Sequence Type 131. AAC 2014:58:4997-5004. Brannon JR, Dunigan TL, Beebout CJ, et al. Invasion of vaginal epithelial cells by uropathogenic Escherichia coli. Nature Communications 2020;11:2803. Brumfitt W, ... | [
"IT001-310 Protocol Amendment 1 12-5-2022 | VV-TMF-165994 | 1.0",
"APPENDIX 1 RATIONALE FOR AMOXICILLIN/CLAVULANATE AS COMPARATOR IN UNCOMPLICATED UTI TRIAL",
"'Indication:",
"3. Availability of data regarding the degree of asymptomatic bacteriuria:",
"REFERENCES:",
"APPENDIX 2 SCHEDULE OF STUDY ASSESSMEN... |
NCT05585307 | 1 | INTRODUCTION | 1. INTRODUCTION Substudy-01 will evaluate the safety, pharmacokinetics (PK), and antiviral activity of GS-5894 given as monotherapy in people with HIV-1 (PWH), who are either treatment-naive or treatment-experienced but naive to nonnucleoside reverse transcriptase inhibitor (NNRTI) class and have not received any antir... | [] |
NCT05585307 | 1.1 | Rationale for Substudy-01 | 1.1. Rationale for Substudy-01 Current first-line ART regimens consist of 2 or 3 ARV drugs, often coformulated, allowing a one-pill, once-daily oral treatment regimen; these regimens result in virologic suppression in more than 80% of PWH {Department of Health and Human Services (DHHS) 2018}, {Gunthard 2016}, {European... | [] |
NCT05585307 | 1.2 | Background on Study Interventions Used in Substudy-01 | 1.2. Background on Study Interventions Used in Substudy-01 | [] |
NCT05585307 | 1.2.1 | GS–5894 | 1.2.1. GS–5894 | [] |
NCT05585307 | 1.2.1.1 | General Information | 1.2.1.1. General Information GS-5894 is a novel NNRTI being developed as a once-weekly oral treatment for HIV-1 infection. In vitro antiviral testing has demonstrated that GS-5894 is a potent and selective nonnucleoside inhibitor of HIV-1 replication, showing strong antiviral activity against clinical isolates from all... | [
"Preliminary PK Summary:",
"Safety Summary:"
] |
NCT05585307 | 1.3 | Rationale for Dose Selection of Study Drug | 1.3. Rationale for Dose Selection of Study Drug Selection of the GS-5894 doses for this study takes into consideration the available safety, tolerability, and PK data for GS-5894 from the ongoing FIH study with oral single and multiple ascending doses in healthy volunteers (Study GS-US-544-5906), as well as emerging pr... | [] |
NCT05585307 | 1.4 | Risk/Benefit Assessment for Substudy-01 | 1.4. Risk/Benefit Assessment for Substudy-01 Potential risks to participants could include prolonged exposure for several weeks to subtherapeutic concentrations of the study drug, which can lead to HIV-1 developing resistance to the study drug and potentially to the study drug class and could limit future treatment opt... | [] |
NCT05585307 | 2 | OBJECTIVES AND ENDPOINTS | 2. OBJECTIVES AND ENDPOINTS Objectives and endpoints are described in Section 2 of the master protocol. | [] |
NCT05585307 | 3 | STUDY DESIGN | 3. STUDY DESIGN | [] |
NCT05585307 | 3.1 | Study Design Overview | 3.1. Study Design Overview This substudy is being conducted as part of an umbrella study as described in the master protocol. Substudy-01 is an open-label, Phase 1b, single/multiple-dose, multicohort study to evaluate the safety, PK, and antiviral activity of GS-5894 given as monotherapy in PWH who are either treatment... | [] |
NCT05585307 | 3.1.1 | Dose Selection/Modification | 3.1.1. Dose Selection/Modification Enrollment and dosing with GS-5894 will begin with Cohort 1. The dose and regimen of GS-5894 for Cohort 1 is defined in Section 5.2.4. A summary of SRT reviews, dose decisions and cohort progression applicable to this substudy is included in Section 3.1.1 of the master protocol. | [] |
NCT05585307 | 3.2 | Duration of Intervention | 3.2. Duration of Intervention Participants will be under evaluation in this Substudy-01 for 39 days. Participants will receive single or multiple doses of GS-5894 starting on Day 1. Participants will then initiate a BVY or another non-NNRTI-based SOC ART regimen on Day 11 following study assessments to provide coverage... | [] |
NCT05585307 | 3.3 | Substudy-01-Specific Discontinuation Criteria | 3.3. Substudy-01-Specific Discontinuation Criteria Substudy criteria for early discontinuation for the individual participants are described in Section 3.3.1 of the master protocol. | [] |
NCT05585307 | 3.4 | Definitions for Time of Primary Endpoint and End of Study | 3.4. Definitions for Time of Primary Endpoint and End of Study The definitions for time of primary endpoint and end of study for each substudy are described Section 3.4 of the master protocol. | [] |
NCT05585307 | 4 | PARTICIPANT POPULATION | 4. PARTICIPANT POPULATION | [] |
NCT05585307 | 4.1 | Number of Participants and Participant Selection for Substudy-01 | 4.1. Number of Participants and Participant Selection for Substudy-01 In Substudy-01, up to approximately 5 cohorts of at least 6 participants each will be enrolled. Participant replacement is described in Section 4.1.1 of the master protocol. | [] |
NCT05585307 | 4.2 | Substudy-01-Specific Inclusion Criteria | 4.2. Substudy-01-Specific Inclusion Criteria Inclusion criteria applicable to all substudies is provided in Section 4.2 of the master protocol. In addition to meeting the inclusion criteria in the master protocol, participants must also meet the following inclusion criteria to be eligible for participation in this subs... | [] |
NCT05585307 | 4.3 | Substudy-01-Specific Exclusion Criteria | 4.3. Substudy-01-Specific Exclusion Criteria Exclusion criteria applicable to all substudies are provided in Section 4.3 of the master protocol. In addition to not meeting any of the exclusion criteria in the master protocol, participants must not meet the following exclusion criterion to be eligible for participation ... | [] |
NCT05585307 | 5 | STUDY INTERVENTIONS AND CONCOMITANT MEDICATIONS | 5. STUDY INTERVENTIONS AND CONCOMITANT MEDICATIONS | [] |
NCT05585307 | 5.1 | Enrollment and Treatment Code Access | 5.1. Enrollment and Treatment Code Access Participant enrolment procedures are described in Section 5.1 of the master protocol. | [] |
NCT05585307 | 5.2 | Description and Handling of GS-5894 and Commercially Available BVY | 5.2. Description and Handling of GS-5894 and Commercially Available BVY Commercially available BVY will be provided by the sponsor for use during the study as applicable. Further information regarding storage and handling are available in the prescribing information for the commercial BVY product. The description and h... | [] |
NCT05585307 | 5.2.1 | Formulation | 5.2.1. Formulation GS-5894 tablets are available in strengths of 75 and 600 mg. GS-5894 tablets, 75 mg, are round, plain-faced, film-coated, gray-colored tablets. GS-5894 tablets, 600 mg, are oval, plain-faced, film-coated, gray-colored tablets. In addition to the active ingredient, GS-5894 tablets, 75 mg and 600 mg, a... | [] |
NCT05585307 | 5.2.2 | Packaging and Labeling | 5.2.2. Packaging and Labeling GS-5894 tablets are packaged in white, high-density polyethylene bottles containing silica gel desiccant and polyester coil packing material. Each bottle is enclosed with a white continuous-thread, child-resistant, polypropylene screw cap with an induction-sealed, aluminum-faced liner. Stu... | [] |
NCT05585307 | 5.2.3 | Storage and Handling | 5.2.3. Storage and Handling GS-5894 tablets should be stored below 30 C. Storage conditions are specified on the label. GS-5894 should be stored in a securely locked area, accessible only to authorized site personnel. To ensure the stability of GS-5894 and proper identification, the drug product should not be stored in... | [] |
NCT05585307 | 5.2.4 | Dosage and Administration | 5.2.4. Dosage and Administration Single or multiple doses of GS-5894 will be administered starting on Day 1. The dose, dose regimen, and meal requirements for administration of GS-5894 in Cohort 1 are provided in Table 4. Subsequent cohort dose, dosing regimens (ie, single or multiple doses), meal requirements (fasted ... | [] |
NCT05585307 | 5.3 | Prior and Concomitant Medications | 5.3. Prior and Concomitant Medications See Section 5.3 of the master protocol for information on prior and concomitant medication rules applicable to all substudies including restricted medications through Day 11. Medications prohibited from after the last dose of study drug on Day 11 through Day 39 in this substudy ar... | [
"ARVs = antiretrovirals"
] |
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