protocol_id stringclasses 263
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NCT02839746 | 9.2 | SETTING | 9.2 SETTING It is planned that data of approximately 1.087 patients will be collected prospectively from approximately 200 sites in Spain. There are planned 6 participating autonomous communities: Madrid, Cataluña, Galicia, Andalucía, Comunidad Valenciana and País Vasco. | [] |
NCT02839746 | 9.2.1 | Selection of sites: | 9.2.1 Selection of sites: Cardiologists and non-cardiologist sites regularly prescribing Pradaxa® and VKA for stroke prevention in non-valvular atrial fibrillation according to the respective Summary of Product Characteristics will participate. Selected sites should include those physicians (e.g. cardiologists, non-car... | [] |
NCT02839746 | 9.2.2 | Inclusion criteria: | 9.2.2 Inclusion criteria: - Written informed consent prior to participation - Female and male patients ≥18 years of age with a diagnosis of non-valvular atrial fibrillation. - At least 6 months of continuous VKA treatment for stroke prevention prior to baseline assessment. - Patients switched to Pradaxa® according to S... | [] |
NCT02839746 | 9.2.3 | Exclusion criteria: | 9.2.3 Exclusion criteria: - Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC). - Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in non-valvular atrial fibrillation. - Current participation in any clinical trial of a drug or de... | [] |
NCT02839746 | 9.2.4 | Removal of patients from the study | 9.2.4 Removal of patients from the study Every patient has the right to withdraw consent at any time during the study, without the need for justification and without any impact on the routine therapy. Boehringer Ingelheim reserves the right to discontinue the study overall or at a particular study site at any time for ... | [] |
NCT02839746 | 9.2.5 | Visit schedule | 9.2.5 Visit schedule Collection of patient data should be managed during routine practice visits. The timeschedule below can only be a recommendation; if a patient does not visit the site at these time points, data will not be collected (no visits will be conducted solely for study purposes). Visits cannot be performed... | [
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"Baseline visit:",
"Initiation period:",
"Continuation period:",
"Description and justification of patient questionnaires:",
"- PACT-Q:"
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NCT02839746 | 9.2.6 | Treatments | 9.2.6 Treatments Patients will be switched from standard care VKA treatment to Pradaxa® - Pradaxa® 110 mg hard capsules - Pradaxa® 150 mg hard capsules Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules contain Dabigatran etexilate (active ingredient: Dabigatran). Patients will receive daily dose of Pradaxa® according t... | [] |
NCT02839746 | 9.2.7 | Concomitant medications and restrictions | 9.2.7 Concomitant medications and restrictions All concomitant medications are prescribed based on the underlying medical condition and upon the discretion of the treating physician. No treatment will be withheld from the patients. Any prescription is in the responsibility of the treating physician. | [] |
NCT02839746 | 9.2.8 | Representativeness of the study population: | 9.2.8 Representativeness of the study population: Inclusion and exclusion criteria have been limited to the respective SmPCs of Pradaxa®. Therefore the patient population recruited in this non-interventional study can be seen as representative for patients receiving VKA therapy and subsequent initiation of treatment wi... | [] |
NCT02839746 | 9.4 | VARIABLES | 9.4 VARIABLES | [] |
NCT02839746 | 9.4.1 | Primary objective: | 9.4.1 Primary objective: Outcome 1: Mean PACT-Q2 scores at second and last assessment compared to baseline assessment. Outcome 2: Mean PACT-Q2 score at last assessment compared to second assessment. | [] |
NCT02839746 | 9.4.2 | For Secondary objectives | 9.4.2 For Secondary objectives Outcome 1: Characterization of patients according to - - Age - - Gender - - CHA2DS2-VASc score [\(R10-5332\)](#page-37-0) - - HAS-BLED score [\(R10-6394\)](#page-37-1) - - Kidney function (creatinine clearance) - - Stroke and/or bleeding related risk factors in medical history and at base... | [] |
NCT02839746 | 9.5 | DATA SOURCES | 9.5 DATA SOURCES Data will be newly collected. Patients will be asked to complete the respective questionnaires during their routine visits. Patient demographic data, concomitant diseases and concomitant therapies will be completed based on the physician´s records. Information on Pradaxa® and/or VKA dosing will be coll... | [] |
NCT02839746 | 9.6 | STUDY SIZE | 9.6 STUDY SIZE It is planned that a total of 1.807 patients from Spain will be recruited for the study. The planned total sample size is jointly determined by the following sample size calculations and additional non-statistical considerations, including feasibility assessments for each participating autonomous communi... | [
"Boehringer Ingelheim Page 24 of 49 Non-interventional Study Protocol BI Study Number 1160.253"
] |
NCT02839746 | 9.7 | DATA MANAGEMENT | 9.7 DATA MANAGEMENT A data management plan (DMP) will be created to describe all functions, processes, and specifications for data collection, cleaning and validation. The electronic CRFs (eCRFs) will include programmable edits to obtain immediate feedback if data are missing, out of range, illogical or potentially err... | [] |
NCT02839746 | 9.8 | DATA ANALYSIS | 9.8 DATA ANALYSIS | [] |
NCT02839746 | 9.8.1 | STUDY DESIGN | 9.8.1 STUDY DESIGN In this non-interventional study, cross-sectional data at study baseline and longitudinal follow-up data over 6 months will be collected for non-valvular AF patients with a VKA therapy and subsequent initiation of Pradaxa®. Baseline data will be described using a cross-sectional approach. Data from t... | [] |
NCT02839746 | 9.8.2 | PLANNED ANALYSES | 9.8.2 PLANNED ANALYSES Analyses will be performed by Boehringer Ingelheim's designees. The main analysis population will consist of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). Summary statistics for continuous variables will include the N, mean, standard deviat... | [] |
NCT02839746 | 9.8.2.1 | Main Analyses | 9.8.2.1 Main Analyses Patient demographics and disease characteristics at baseline as described in section 8.3.2 will be summarized descriptively for all eligible patients in the study. This analysis may be repeated by additional relevant factors that will be specified in the SEAP. If deemed appropriate, continuous and... | [] |
NCT02839746 | 9.8.2.2 | Further Analyses | 9.8.2.2 Further Analyses Mean differences in PACT-Q2 between other assessment time points will be analyzed using the same statistical procedure as described for the primary endpoint. | [] |
NCT02839746 | 9.8.2.3 | Safety Analyses | 9.8.2.3 Safety Analyses Safety analyses will include all enrolled patients with an actual follow-up. Statistical analysis and reporting of AEs will be descriptive in nature, will be based on BI standards, and will focus on adverse drug reactions (i.e. AEs related to anticoagulation treatment). No hypothesis testing is ... | [] |
NCT02839746 | 9.8.2.4 | Schedule of Planned Analyses | 9.8.2.4 Schedule of Planned Analyses All planned analyses as specified in Section 9.8.2.1 to 9.8.2.3 will be performed once the data collection is completed, the data sets are cleaned, and the database is locked. One final report will be prepared at the completion of the study. | [] |
NCT02839746 | 9.8.3 | HANDLING OF MISSING DATA | 9.8.3 HANDLING OF MISSING DATA Every reasonable attempt will be undertaken to ensure completeness of data collection. Imputation will be permitted, if deemed appropriate and on a case-by-case basis, depending on the extent and distribution of missing values, and will be described in the SEAP. The percentage of and reas... | [] |
NCT02839746 | 9.9 | QUALITY CONTROL | 9.9 QUALITY CONTROL The following processes will be implemented to ensure data completeness and data quality:
Data Edit Checks: The electronic CRF (eCRF) will include programmable edit checks to obtain feedback if data is missing, out of range, illogical or potentially erroneous. These checks will be performed once da... | [
"Data Edit Checks:",
"Medical monitoring:",
"Source data verification:"
] |
NCT02839746 | 9.10 | LIMITATIONS OF THE RESEARCH METHODS | 9.10 LIMITATIONS OF THE RESEARCH METHODS
Boehringer Ingelheim Page 29 of 49 Non-interventional Study Protocol BI Study Number 1160.253 Proprietary confidential information © 2016 Boehringer Ingelheim International GmbH or one or more of its affiliated companies Consecutive enrolment will be employed to ensure that spe... | [
"Boehringer Ingelheim Page 29 of 49 Non-interventional Study Protocol BI Study Number 1160.253",
"Selection bias:",
"Loss to follow-up:",
"Recall bias:",
"Confounding:"
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NCT02839746 | 9.11 | OTHER ASPECTS | 9.11 OTHER ASPECTS | [] |
NCT02839746 | 9.11.1 | INFORMED CONSENT, DATA PROTECTION, STUDY RECORDS | 9.11.1 INFORMED CONSENT, DATA PROTECTION, STUDY RECORDS The study will be carried out in compliance with the protocol, the principles laid down in the Declaration of Helsinki, and relevant BI Standard Operating Procedures (SOPs). Standard medical care (prophylactic, diagnostic and therapeutic procedures) remains in the... | [] |
NCT02839746 | 9.11.1.1 | STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED CONSENT | 9.11.1.1 STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED CONSENT This study will be initiated only after all required legal documentation has been reviewed and approved by the respective Independent Ethics Committee (IEC) and competent authority (CA) according to national and international regulations. The same appli... | [] |
NCT02839746 | 9.11.1.2 | DATA QUALITY ASSURANCE | 9.11.1.2 DATA QUALITY ASSURANCE A quality assurance audit/inspection of this study may be conducted by the sponsor or sponsor's designees or by IECs or by regulatory authorities. The quality assurance auditor will have access to all medical records, the investigator's study-related files and correspondence, and the inf... | [] |
NCT02839746 | 9.11.1.3 | RECORDS | 9.11.1.3 RECORDS Case Report Forms (CRFs) for individual patients will be provided by the sponsor via remote data capture. All of the clinical data and site/investigator characteristics will be captured via a web-based EDC system. The site staff will enter and edit the data via a secure network, with secure access feat... | [] |
NCT02839746 | 9.11.1.3.1 | Source documents | 9.11.1.3.1 Source documents Source documents provide evidence for the existence of the patient and substantiate the integrity of the data collected. Source documents are filed at the investigator's site. Data entered in the eCRFs that are transcribed from source documents must be consistent with the source documents or... | [] |
NCT02839746 | 9.11.1.3.2 | Direct access to source data and documents | 9.11.1.3.2 Direct access to source data and documents The investigator / institution will permit study-related monitoring, audits, IEC review and regulatory inspection, providing direct access to all related source data / documents. eCRFs and all source documents, including progress notes and copies of laboratory and m... | [] |
NCT02839746 | 9.11.1.4 | STATEMENT OF CONFIDENTIALITY | 9.11.1.4 STATEMENT OF CONFIDENTIALITY Individual patient medical information obtained as a result of this study is considered confidential and disclosure to third parties is prohibited with the exceptions noted below. Patient confidentiality will be ensured by using patient identification code numbers. Treatment data m... | [] |
NCT02839746 | 9.11.1.5 | COMPLETION OF STUDY | 9.11.1.5 COMPLETION OF STUDY The EC/competent authority needs to be notified about the end of the study (last patient out), or early termination of the study. | [] |
NCT02839746 | 10 | PROTECTION OF HUMAN SUBJECTS | 10. PROTECTION OF HUMAN SUBJECTS Please refer to [section 8.10.1](#page-29-0) | [] |
NCT02839746 | 11 | MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS | 11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS | [] |
NCT02839746 | 11.1 | DEFINITIONS OF ADVERSE EVENTS | 11.1 DEFINITIONS OF ADVERSE EVENTS
Adverse event: An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship... | [
"Adverse event:",
"Serious adverse event:",
"Intensity of adverse event:",
"Causal relationship of adverse event:",
"Boehringer Ingelheim Page 35 of 49 Non-interventional Study Protocol BI Study Number 1160.253"
] |
NCT02839746 | 11.2 | ADVERSE EVENT AND SERIOUS ADVERSE EVENT REPORTING | 11.2 ADVERSE EVENT AND SERIOUS ADVERSE EVENT REPORTING All adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e., from signing the informed consent onwards through the observational phase) will be collected, documented and reported to the sponsor by the investigator on the app... | [
"Pregnancy:"
] |
NCT02839746 | 11.3 | TIME WINDOWS | 11.3 TIME WINDOWS To fulfil the regulatory requirements for expedited safety reporting, the sponsor evaluates whether a particular adverse event is "listed", i.e. is a known side effect of the drug or not. Therefore a unique reference document for the evaluation of listedness needs to be provided. For Pradaxa® this is ... | [] |
NCT02839746 | 12 | PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS | 12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS Results of this non-interventional study will be disclosed on external websites according to BI SOP. In addition, a study specific publication plan will be developed to describe planned publications for overall study results. | [] |
NCT02839746 | 13 | REFERENCES | 13. REFERENCES | [] |
NCT02839746 | 13.1 | PUBLISHED REFERENCES | 13.1 PUBLISHED REFERENCES - P13-05668 Monz BU, Connolly SJ, Korhonen M, Noack H, Pooley J Assessing the impact of dabigatran and warfarin on health-related quality of life: results from an RE-LY sub-study. Int J Cardiol 168 (3), 2540 - 2547 (2013). - R10-5332 Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM Refini... | [] |
NCT02839746 | 13.2 | UNPUBLISHED REFERENCES | 13.2 UNPUBLISHED REFERENCES None.
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS
PACT-Q2 (Perception AntiCoagulant Treatment Questionnaire) - The purpose of this questionnaire is to understand your expectations and to assess your satisfaction with your anticoagulant treatment (treatment that stops the blood from clotting). -... | [
"ANNEX 1. LIST OF STAND-ALONE DOCUMENTS",
"PACT-Q2 (Perception AntiCoagulant Treatment Questionnaire)",
"REVIEW COPY Do not use without permission",
"Burden of Disease and Treatment",
"Please check one box per line.",
"Anticoagulant Treatment Satisfaction",
"Please check one box per line.",
"ANNEX 2. ... |
NCT02842086 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT02842086 | 1.1 | Background | 1.1. Background The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that there were 1.5 million new HIV-1 infections in 2020 despite widespread knowledge of the protective effects of abstinence, monogamy, and condoms in preventing new HIV-1 infections {UNAIDS, 2020}. The principal interventions used to pr... | [] |
NCT02842086 | 1.2 | Tenofovir Alafenamide (TAF, GS-7340) | 1.2. Tenofovir Alafenamide (TAF, GS-7340) | [] |
NCT02842086 | 1.2.1 | General Information | 1.2.1. General Information Tenofovir alafenamide (GS-7340, TAF, or L-Alanine, N-[(S)-[[(1R)-2-(6-amino-9H-purin-9 yl)1-methylethoxy]methyl]/phenoxyphosphinyl]-, 1-methylethyl ester) is an oral prodrug of TFV, a nucleotide analog that inhibits HIV-1 reverse transcription. Tenofovir is metabolized intracellularly to the ... | [] |
NCT02842086 | 1.2.2 | Nonclinical Studies of F/TAF for PrEP | 1.2.2. Nonclinical Studies of F/TAF for PrEP Nonclinical pharmacology studies in rhesus macaques show that orally administered F/TAF, at doses resulting in PBMC exposures that are consistent with those achieved in humans administered a dose of F/TAF 200/25 mg, effectively prevents SHIV infection. Using a design similar... | [] |
NCT02842086 | 1.2.3 | Preclinical Pharmacology and Toxicology | 1.2.3. Preclinical Pharmacology and Toxicology | [] |
NCT02842086 | 1.2.3.1 | Primary Pharmacodynamics | 1.2.3.1. Primary Pharmacodynamics TAF is metabolized to TFV, a nucleotide analog (ie, a nucleoside monophosphate analog) which is not dependent on an intracellular nucleoside kinase activity for the first step in the conversion to the active metabolite, TFV-DP. The cellular enzymes responsible for TFV metabolism to the... | [] |
NCT02842086 | 1.2.3.2 | Safety Pharmacology | 1.2.3.2. Safety Pharmacology TAF monofumarate (GS-7430-02) has been evaluated to determine potential effects on the central nervous system (R990188), renal system (R990186), cardiovascular (D2000006) and gastrointestinal systems (R990187). Single doses did not induce pharmacologic effects on the central nervous system ... | [] |
NCT02842086 | 1.2.4 | Nonclinical Pharmacokinetics | 1.2.4. Nonclinical Pharmacokinetics All nonclinical PK experiments in this section were performed using TAF monofumarate (GS-7340-02), and all study data described in this section reflect the dosage of the monofumarate. For reference, 100 mg of TAF monofumarate is equivalent to 80 mg of the GS-7340 free base (TAF). Pla... | [] |
NCT02842086 | 1.2.5 | Nonclinical Toxicology | 1.2.5. Nonclinical Toxicology TAF monofumarate (GS-7340-02) was evaluated in mice, rats, dogs, and monkeys for treatment periods up to 9-months and was negative in genetic toxicology studies. In chronic studies in rats, bone (atrophy of metaphyseal cancellous bone) and kidneys (karyomegaly) were the primary target orga... | [] |
NCT02842086 | 1.2.6 | Clinical Trials of Single Agent Tenofovir Alafenamide (TAF, GS-7340) or Fixed-Dose Combination Emtricitabine/Tenofovir Alafenamide (F/TAF) | 1.2.6. Clinical Trials of Single Agent Tenofovir Alafenamide (TAF, GS-7340) or Fixed-Dose Combination Emtricitabine/Tenofovir Alafenamide (F/TAF) Clinical trials entailing the use of tenofovir alafenamide include: - GS-US-120-1101, a Phase 1/2 study of the pharmacokinetics and antiviral activity of GS-7340 (50 mg and 1... | [] |
NCT02842086 | 1.3 | Emtricitabine (FTC, Emtriva®) | 1.3. Emtricitabine (FTC, Emtriva®) Further information regarding Emtriva is available in the prescribing information, an overview is provided below. | [] |
NCT02842086 | 1.3.1 | General Information | 1.3.1. General Information Emtricitabine (5-fluoro-1-[(2R, 5S)-2-(hydroxymethyl)-[1, 3]-oxathiolan-5-yl] cytosine, FTC) is a NRTI that has demonstrated potent and selective inhibition of the HIV. In HIV-infected adults, FTC is administered as a 200 mg once daily dose concurrently with other ARV drugs. The 200 mg FTC ca... | [] |
NCT02842086 | 1.4 | Fixed-Dose Combination of Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) | 1.4. Fixed-Dose Combination of Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Further information is available in the Prescribing Information for Truvada (emtricitabine/tenofovir disoproxil fumarate). | [] |
NCT02842086 | 1.5 | Rationale for This Study | 1.5. Rationale for This Study Based on available data, the use of F/TAF for PrEP would provide a new option for persons with high sexual risk of HIV-1 acquisition. Based on data with F/TAF-based regimens used for treatment of chronic HIV-1 infection, the improved safety profile of F/TAF (relative to F/TDF) reduces the ... | [] |
NCT02842086 | 1.6 | Rationale for Dose | 1.6. Rationale for Dose The 200 mg dose represents the dose of FTC in the FDC, Truvada, which is approved for a PrEP indication in the US. Based upon results of the Phase 1 Study GS-US-120-0104, in which increasing doses of TAF (8 mg, 25 mg, and 40 mg) were administered to HIV-1–infected participants in 10 days of mono... | [] |
NCT02842086 | 1.7 | Risk/Benefit Assessment for the Study | 1.7. Risk/Benefit Assessment for the Study During a pandemic, additional potential risks to participants may include adequate study drug availability, interruptions to the study visit schedule, and adherence to protocol-specified safety monitoring or laboratory assessments. Refer to [Appendix 8](#page-130-0) for furthe... | [] |
NCT02842086 | 1.8 | Compliance | 1.8. Compliance This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), and all applicable regulatory requirements.
2\ OBJECTIVES The prima1y objective of this study is: • To assess the rates of HIV-I infection in MSM and TGW who have sex with men who are administered daily F/TAF o... | [
"2\\ OBJECTIVES"
] |
NCT02842086 | 3 | STUDY DESIGN | 3. STUDY DESIGN | [] |
NCT02842086 | 3.1 | Endpoints | 3.1. Endpoints | [] |
NCT02842086 | 3.1.1 | Primary Endpoint | 3.1.1. Primary Endpoint The primary endpoint will be the incidence of HIV-1 infection per 100 person years (PY) when all participants have a minimum follow up of 48 weeks and at least 50% of the participants have 96 weeks of follow up after randomization. HIV-1 infection is defined by one or more of the following crite... | [] |
NCT02842086 | 3.1.2 | Secondary Endpoints | 3.1.2. Secondary Endpoints The key (α-controlled) secondary endpoints in the blinded phase are (in the following order): - The percent change from baseline in hip BMD at Week 48 in a subset of participants - The percent change from baseline in spine BMD at Week 48 in a subset of participants - Assessment of renal bioma... | [] |
NCT02842086 | 3.2 | Study Design | 3.2. Study Design This protocol describes a randomized, double-blind comparison of the safety and efficacy of F/TAF versus F/TDF administered once daily for at least 96 weeks in HIV-I-negative adult MSM or TGW (male at birth) who have sex with men and ai·e at risk of HIV-1 infection. All participants must meet all elig... | [
"Study Treatments",
"Blinded Phase:",
"Open Label Phase and Open Label Extension Phase:"
] |
NCT02842086 | 4 | PARTICIPANT POPULATION | 4. PARTICIPANT POPULATION | [] |
NCT02842086 | 4.1 | Number of Participants and Participant Selection | 4.1. Number of Participants and Participant Selection Five thousand participants who meet all of the Inclusion and none of the Exclusion criteria will be enrolled. | [] |
NCT02842086 | 4.2 | Inclusion Criteria | 4.2. Inclusion Criteria Participants must be at high risk of sexual acquisition of HIV and meet all of the following inclusion criteria to be eligible for participation in this study. - 1) HIV-1–negative status - 2) MSM or TGW (male at birth) who have at least one of the following: - a) condomless anal intercourse with... | [] |
NCT02842086 | 4.3 | Exclusion Criteria | 4.3. Exclusion Criteria Participants who meet any of the following exclusion criteria are not to be enrolled in this study. - 1) Known hypersensitivity to the study drug, the metabolites, or formulation excipient. - 2) Have a suspected or known active, serious infection(s) - 3) Acute viral hepatitis A, B or C or eviden... | [] |
NCT02842086 | 5 | INVESTIGATIONAL MEDICINAL PRODUCTS | 5. INVESTIGATIONAL MEDICINAL PRODUCTS | [] |
NCT02842086 | 5.1 | Enrollment | 5.1. Enrollment This is a randomized, double-blind study. It is the responsibility of the investigator to ensure that the participant is eligible for the study prior to randomization. Randomization cannot occur until participant eligibility has been confirmed. Once eligibility has been confirmed, each participant will ... | [] |
NCT02842086 | 5.2 | Description and Handling | 5.2. Description and Handling | [] |
NCT02842086 | 5.2.1 | Formulation | 5.2.1. Formulation | [] |
NCT02842086 | 5.2.1.1 | Emtricitabine/Tenofovir Alafenamide (F/TAF) 200 mg/25 mg and Matching Placebo | 5.2.1.1. Emtricitabine/Tenofovir Alafenamide (F/TAF) 200 mg/25 mg and Matching Placebo Emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets are blue, rectangular-shaped, filmcoated tablets, debossed with "GSI" on one side of the tablet and with "225" on the other side of the tablet. Each tablet core contains 200 mg... | [] |
NCT02842086 | 5.2.1.2 | Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Tablets and Matching Placebo | 5.2.1.2. Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Tablets and Matching Placebo Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablets are blue, capsule-shaped, film-coated tablets debossed with "GILEAD" on one side and are plain-faced on the other side of the tablet. Each tablet core contains 200 ... | [] |
NCT02842086 | 5.2.2 | Packaging and Labeling | 5.2.2. Packaging and Labeling Emtricitabine/Tenofovir Alafenamide (F/TAF) tablets and placebo-to-match F/TAF tablets are packaged in a white high-density polyethylene (HDPE) bottle. Each bottle contains 30 tablets, silica gel desiccant, and polyester packing material. Each bottle is enclosed with a white, continuous th... | [] |
NCT02842086 | 5.2.3 | Storage and Handling | 5.2.3. Storage and Handling Emtricitabine/Tenofovir Alafenamide (F/TAF) and the placebo-to-match F/TAF tablets should be stored at a controlled room temperature of 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Storage conditions are specified on the label. Emtricitabine/Tenofovir Disoprox... | [] |
NCT02842086 | 5.3 | Dosage and Administration | 5.3. Dosage and Administration Emtricitabine/Tenofovir Alafenamide (F/TAF), placebo-to-match F/TAF, F/TDF, and placebo-to-match F/TDF tablets will be provided by Gilead. Study drug will be dispensed to participants at the Day 1 visit. Participants will be instructed to take their first dose of study medication followin... | [] |
NCT02842086 | 5.4 | Prior and Concomitant Medications | 5.4. Prior and Concomitant Medications Medications and use of herbal/natural supplements listed in the following table are excluded or should be used with caution while participants are taking study drug on the study due to potential drug-drug interactions with F/TAF. Table 5-1. Prior and Concomitant Medications | Medi... | [] |
NCT02842086 | 5.5 | Dispensing and Accountability of Investigational Medicinal Product | 5.5. Dispensing and Accountability of Investigational Medicinal Product The investigator is responsible for ensuring adequate accountability of all used and unused Investigational Medicinal Product (IMP) or study drug. The investigator [or designee (eg, study center pharmacist)] will acknowledge receipt of the study dr... | [] |
NCT02842086 | 6 | STUDY PROCEDURES | 6. STUDY PROCEDURES The study procedures to be conducted for each participant enrolled in the study are presented in tabular form in [Appendix 2](#page-99-0) and [Appendix 3](#page-103-0) and described in the text that follows. The investigator must document any deviation from protocol procedures and notify the sponsor... | [] |
NCT02842086 | 6.1 | Participant Enrollment and Treatment Assignment | 6.1. Participant Enrollment and Treatment Assignment It is the responsibility of the investigator to ensure that participants are eligible for study prior to enrollment. | [] |
NCT02842086 | 6.2 | Pretreatment Assessments | 6.2. Pretreatment Assessments | [] |
NCT02842086 | 6.2.1 | Screening Visit | 6.2.1. Screening Visit The following assessments will be performed at the screening visit: - Written informed consent completed prior to any other assessments - Medical history including information about alcohol use in the past year and self-reported sexual risk events and medications used by the participant in the 30... | [
"Hepatitis C testing"
] |
NCT02842086 | 6.2.2 | Day 1 Visit (Baseline) | 6.2.2. Day 1 Visit (Baseline) Day 1 procedures and randomization may occur as soon as all eligibility criteria are confirmed. The Day 1 visit must occur within 30 days after the screening visit. The participant must complete all Day 1 procedures before being dispensed study drug. Initiation of treatment with study drug... | [] |
NCT02842086 | 6.3 | Treatment Assessments Blinded Phase (\Veeks 4, 12, and Every 12 Weeks Until the end of blinded treatment phase visit) | 6.3. Treatment Assessments Blinded Phase (\Veeks 4, 12, and Every 12 Weeks Until the end of blinded treatment phase visit) The following evaluations ai·e to be completed at the Weeks 4, 12, and eve1y 12 weeks visits until the end of blinded ti·eatinent phase visit unless othe1wise specified. All study visits are to be ... | [] |
NCT02842086 | 6.4 | End of Blinded Treatment Phase Visit | 6.4. End of Blinded Treatment Phase Visit Once all participants have had at least 96 weeks of follow up after randomization and upon notification by Gilead, all participants will return to the study center for an end of blinded treatment phase visit (may coincide with their next scheduled study visit). ![](page50Pictur... | [
"I"
] |
NCT02842086 | 6.5 | Treatment Assessments Open-Label Phase and Open-Label Extension Phase | 6.5. Treatment Assessments Open-Label Phase and Open-Label Extension Phase All study visits in the OL phase and OL extension phase ai·e to be scheduled relative to the end of blinded ti·eatment phase visit date. Study visits ai·e to be completed within ± 14 days of the protocol-specified visit date based on the end of ... | [] |
NCT02842086 | 6.5.1 | Open-Label Phase (Prior to OL Week 96) | 6.5.1. Open-Label Phase (Prior to OL Week 96) Regulai·ly scheduled evaluations will be made on all paiticipants, unless othe1wise specified. - Tai·geted (symptom directed) physical examination (complete physical examination at OL Week 48 only) - Review of AEs and changes in concomitant medications, including assessment... | [] |
NCT02842086 | 6.5.2 | Open-Label Extension Phase (From OL Week 96) | 6.5.2. Open-Label Extension Phase (From OL Week 96) I The following assessments are to be completed at eve1y visit for paiticipants continuing in the OL extension phase, unless othe1wise specified. For paiticipants who choose not to continue in the OL extension phase, the ESDD assessments (prior to OL Week 96) should b... | [] |
NCT02842086 | 6.6 | Unscheduled Visits | 6.6. Unscheduled Visits Additional unscheduled assessments may be performed at the discretion of the investigator (eg, for evaluation of AEs and/or laboratory abnormalities, including assessment of whether any STIs were diagnosed and any treatments were received since last visit). Participants who test HIV positive dur... | [] |
NCT02842086 | 6.7 | Posttreatment Assessments | 6.7. Posttreatment Assessments | [] |
NCT02842086 | 6.7.1 | Early Study Drug Discontinuation Assessments (Prior to OL Week 96) | 6.7.1. Early Study Drug Discontinuation Assessments (Prior to OL Week 96) If the participant discontinues study drug prior to the OL Week 96 visit, the participant will be asked to return to the clinic within 72 hours of stopping study drug for the ESDD visit. - Targeted (symptom directed) physical examination - Review... | [] |
NCT02842086 | 6.7.2 | Early Study Drug Discontinuation Assessments (From OL Week 96) | 6.7.2. Early Study Drug Discontinuation Assessments (From OL Week 96) If the participant discontinues study drug from OL Week 96 visit, the participant will be asked to return to the clinic within 72 hours of stopping study drug for the ESDD visit. - Targeted (symptom directed) physical examination - Review of AEs and ... | [] |
NCT02842086 | 6.7.3 | 30-Day Follow-Up Assessment | 6.7.3. 30-Day Follow-Up Assessment All participants who have received at least one dose of study drug will be required to complete a follow-up visit 30 days (+ 14 days) after discontinuation of the study drug. Participants who permanently discontinue study drug and continue to attend normal study visits (at minimum one... | [] |
NCT02842086 | 6.8 | Criteria for Restarting Study Drug After an Interruption | 6.8. Criteria for Restarting Study Drug After an Interruption If a participant interrupts study dosing temporarily for more than 14 consecutive days, the participant should have samples collected for the following HIV tests prior to restarting study dosing: At a minimum, fourth generation rapid HIV-1 Ab/Ag or third gen... | [] |
NCT02842086 | 6.9 | Criteria for Discontinuation of Study Treatment | 6.9. Criteria for Discontinuation of Study Treatment If a participant discontinues study dosing (for example, as a result of an AE), every attempt should be made to keep the participant in the study and continue to perform the required studyrelated follow up and procedures until the end of blinded treatment phase visit... | [] |
NCT02842086 | 6.10 | Bone Evaluations | 6.10. Bone Evaluations In a subset of participants (except in Ge1many), DXA scans of the hip and spine will be perfo1med throughout the study. During the blinded phase of the study, all DXA substud a · · The Day 1 scan must be completed± 14 days from staii of treatment. All other scans should be completed± 6 weeks of t... | [] |
NCT02842086 | 6.11 | HIV Infection | 6.11. HIV Infection Paiiicipants will be assessed for any recent exposures that the investigator considers high risk for HIV infection at each study visit (including phone contacts and any unscheduled visits) from randomization through the end of study, with HIV testing done as clinically appropriate. Paiiicipants with... | [] |
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