Explore with a no-risk trial

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gov on or before the application due date and time. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide.

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

See Section III of this FOA for information on registration requirements. See more tips for avoiding common errors. Consultation with relevant IC staff at least 10 weeks prior to the application due date is strongly encouraged for new and resubmission applications. If requested, IC staff will consider whether the proposed clinical trial meets the goals and mission of the Institute, whether it addresses one or more high priority research areas, and whether it is appropriate to conduct as an investigator initiated clinical trial.

Scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed trial does not meet the IC's programmatic needs, applicants will be strongly encouraged to consider other Funding Opportunities. Written questions or requests for telephone consultation may be submitted to Trinh Ly, MD trinh.

ly nih. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH.

Applications that are incomplete or non-compliant will not be reviewed. Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Note: Effective for due dates on or after January 25, , the Data Sharing Plan and Genomic Data Sharing Plan GDS as part of the Resource Sharing Plan will not be evaluated at time of review. Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.

Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field s involved, in consideration of the following review criteria and additional review criteria as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field s?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?

If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Is the potential of the intervention to cause physical or psychological harm low? Is the trial appropriately designed to conduct the research efficiently? Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate?

Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection?

Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate?

Is there a plan to obtain required study agent s? Does the application propose to use existing available resources, as applicable? Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions?

Are the procedures for data management and quality control of data adequate at clinical site s or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed?

Is there a plan to complete data analysis within the proposed period of the award? Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application adequately address the capability and ability to conduct the trial at the proposed site s or centers?

Are the plans to add or drop enrollment centers, as needed, appropriate? As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources e.

Are potential challenges and corresponding solutions discussed e. For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1 risk to subjects, 2 adequacy of protection against risks, 3 potential benefits to the subjects and others, 4 importance of the knowledge to be gained, and 5 data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1 the justification for the exemption, 2 human subjects involvement and characteristics, and 3 sources of materials.

For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: 1 description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; 2 justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; 3 interventions to minimize discomfort, distress, pain and injury; and 4 justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals.

Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. For Renewals, the committee will consider the progress made in the last funding period.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.

Reviewers will assess the information provided in this section of the application, including 1 the Select Agent s to be used in the proposed research, 2 the registration status of all entities where Select Agent s will be used, 3 the procedures that will be used to monitor possession use and transfer of Select Agent s , and 4 plans for appropriate biosafety, biocontainment, and security of the Select Agent s.

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1 Data Sharing Plan ; 2 Sharing Model Organisms ; and 3 Genomic Data Sharing Plan GDS. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group s convened by Center for Scientific Review,, in accordance with NIH peer review policy and procedures , using the stated review criteria.

Assignment to a Scientific Review Group will be shown in the eRA Commons. As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit generally the top half of applications under review will be discussed and assigned an overall impact score. Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications. Awardees must comply with any funding restrictions described in Section IV.

Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.

For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award e.

All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

gov: If an award provides for one or more clinical trials. By law Title VIII, Section of Public Law , the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials. NIH encourages registration of all trials whether required under the law or not.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC.

To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies clinical trials to ensure the safety of participants and the validity and integrity of the data.

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions including licensed products and devices for a purpose other than that for which they were licensed in humans under a research protocol must be performed under a Food and Drug Administration FDA investigational new drug IND or investigational device exemption IDE.

Milestones: Future support of a study funded under this FOA is contingent upon adequate participant recruitment based on projected milestones. All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA.

For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

More information is provided at Award Conditions and Information for NIH Grants. Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.

This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

html or call or TDD In accordance with the statutory provisions contained in Section of the Duncan Hunter National Defense Authorization Act of Fiscal Year Public Law , NIH awards will be subject to the Federal Awardee Performance and Integrity Information System FAPIIS requirements.

FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system currently FAPIIS prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.

This provision will apply to all NIH grants and cooperative agreements except fellowships. Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement.

Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of Transparency Act , includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY or later.

All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System FSRS available at www. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR The recipient must also make semiannual disclosures regarding such proceedings.

Proceedings information will be made publicly available in the designated integrity and performance system currently FAPIIS. This is a statutory requirement under section of Public Law , as amended 41 U.

As required by section of Public Law , all information posted in the designated integrity and performance system on or after April 15, , except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. eRA Service Desk Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date , and post-submission issues.

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Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts.

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Awards are made under the authorization of Sections and of the Public Health Service Act as amended 42 USC and and under Federal Regulations 42 CFR Part 52 and 45 CFR Part Weekly TOC for this Announcement NIH Funding Opportunities and Notices Department of Health and Human Services HHS NIH Turning Discovery Into Health ® Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

Department of Health and Human Services. Part 1. Overview Information. Participating Organization s. National Institutes of Health NIH. Components of Participating Organizations.

Funding Opportunity Title. NIDCD Low Risk Clinical Trials in Communication Disorders R01 Clinical Trial Required. Activity Code. Announcement Type. Related Notices. See Notice NOT-OD September 13, - Updates to the Non-Discrimination Legal Requirements for NIH Recipients.

August 5, - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, See Notice NOT-OD August 5, - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements.

See Notice NOT-OD October 28, - Notice to Rescind NOT-DC, "Notice of Invitation for Applicants to NIDCD PAR and PAR to Consult with the NCATS Clinical and Translational Science Award CTSA Trial Innovation Network TIN Prior to Submission".

See Notice NOT-DC October 28, - Notice to rescind NOT-DC, "Notice of Informational Webinar for PAR and PAR Planning to Consult with the Clinical and Translational Science Award CTSA Trial Innovation Network TIN ".

See Notice NOT-DC October 22, - Notice of Informational Webinar for PAR and PAR See Notice NOT-DC May 10, - Notice of NIDCD Withdrawal from Participation in PA February 16, - Notice of Special Interest NOSI : Hearing Healthcare for Adults: Improving Access and Affordability.

Funding Opportunity Announcement FOA Number. Companion Funding Opportunity. Number of Applications. Catalog of Federal Domestic Assistance CFDA Number s.

Funding Opportunity Purpose. Key Dates. Posted Date. Open Date Earliest Submission Date. Letter of Intent Due Date s. Application Due Date s. The first standard due date for this FOA is February 5, AIDS Application Due Date s. The first AIDS application due date for this FOA is May 7, Scientific Merit Review.

Advisory Council Review. Earliest Start Date. Expiration Date. Due Dates for E. Required Application Instructions. Section I. Funding Opportunity Description. Section II. Award Information. Eligibility Information. Section IV. Application and Submission Information. If you cancel your free trial before the expiry date, your credit card will not be charged, and your trial event will be deleted.

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We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events

Explore with a no-risk trial - The NIDCD is committed to identifying effective interventions for the diagnosis, prevention, or treatment of communication disorders by We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic- Missing Our free trial is a great way to explore the ClearEvent platform - at no cost and no risk to you - and learn about how ClearEvent can help you run better events

A lot of providers may not be well versed in sexual health or HIV prevention. We need a lot more education to bring them up to speed on where we are right now.

There's always room for improvement with the way we approach HIV prevention as part of sexual health; as clinicians, we should work harder at helping people achieve the sexual lives they want instead of being judgmental of the kind of sex they're having.

The goal as a medical provider is not to compound the oppressive forces that people may feel in their day-to-day existence. When they come in to see you, they are looking at you to be the oasis in a desert of stigma and bias.

Providers could help normalize and reframe PrEP by emphasizing sexual health and HIV prevention as part of primary care. When a provider is having a conversation about sexual health, we should be asking what it means to have a healthy sex life. What does that look like for you?

What's your priority regarding your sexual health? What would make this visit be successful for you? My name is Dr. Cynthia Rivera. I am the Program Director of the Infectious Diseases Fellowship at Mount Sinai Medical Center in Miami Beach, Florida.

When we look at our Latinx community, we see amongst men who have sex with men and transgender women the high lifetime risk of HIV, but they have one of the lowest rates of PrEP uptake. Based on my experience, multiple factors contribute to this high lifetime risk, including socioeconomic status and access to preventative medical care, as well as cultural perceptions and stigmas around HIV.

There's a lot of views that favor heteronormativity. I have men who are in heterosexual relationships, with or without children, possibly married, who have sex with men but do not identify themselves as gay. And that ties into the cultural construct of machismo.

That's a difficult-to-define term but it is really encompassing a cultural construct on what it means to be masculine. And that may even include certain sexual practices. If the question is not specifically asked, we may not be able to really provide the counseling that's specific to that person's sexual practices.

So, it's really important to understand the culture within the Latinx community to be able to have those open and honest discussions. So, when I'm taking a sexual history, the first thing that I want to convey to patients is that I'm very comfortable having a discussion about sex.

With my Latinx patients, I do have conversations about stigma, about cultural barriers. What I find is that there is a very low level of awareness of the efficacy and the availability of PrEP in the Latinx community. That has to do with perhaps marketing not being provided in that person's dominant language.

Lack of availability of preventative health services. And so patients will often seek a provider when they are ill because of difficulty accessing preventative health, and just a perception that the cost of PrEP is too high, the cost of labs are too high, or perhaps that testing is not available to them.

Getting to the root cause within one's community is central to being able to then have patient navigators in the community to be able to, uh, bring down those barriers.

If the transportation costs are prohibitive, we offer vouchers, more availability of telemedicine appointments, we offer mobile clinics, we just find ways to remove the barriers to care.

Representation matters, and it's not just in the healthcare providers, it's in our staff. Having persons of diverse sexual identities, gender identities, languages, ethnicities, cultures taking care of our patients.

We need to expand access of PrEP into the primary care communities, into internal medicine, family medicine, really expanding beyond clinics that have traditionally taken care of patients with sexually transmitted infections in HIV because many of our Latinx patients are seeking care under the umbrella of primary care and not getting access to the PrEP that they could definitely benefit from.

My training is in general internal medicine, but as well as specialty in HIV. I live in Atlanta, Georgia, currently, and my position at Gilead Sciences is senior director of Global HIV Medical Affairs. Now, if you shift gears and look to who is actually getting PrEP, it's not that same population.

Some of the barriers that I see commonly among young men who have sex with men when it comes to PrEP uptake have partly to do with what's going on in their individual lives and then what happens once they get into the clinical setting.

So with regards to their individual lives, you're dealing with stigma, especially with young people. They're still figuring out what they like sexually.

So, when you hear that immediately, that's a huge barrier because you know, at that point, that the person that you trust to get you HIV prevention is not gonna be receptive to what you're saying.

HIV prevention is a part of our overall sexual health approach and, for me, it's just a matter of really starting as a clinician with a sexual history and having a conversation with patients or individuals that really makes them feel comfortable.

Particularly when we focus on young men who have sex with men, I'm thinking about some of the experiences that they may have had, with society, with discrimination on different levels. The 3 tenets I use with a sexual health conversation is 1, to normalize it—let them know that these are questions that we talk about with everybody.

And then 3, you want to reassure them. So let them know that this conversation that's happening between you and them is gonna be private. The new CDC guidelines upgraded from previous versions…instead of using specific labels of people and groups that would benefit from PrEP, they actually expanded the language to include anyone who is sexually active—adults or adolescents.

It completely changes the game. And so, as clinicians, instead of just looking at people to see if they fit in those boxes about who would benefit from PrEP, it opens it up and encourages us to just have a general sexual health conversation. MSM may not be a sexual identity that patients actually jive with.

And then as far as risk is concerned, when people are having sex, whether it's condomless or not, no one likes to hear that they're necessarily engaging in risky sex.

Our role as healthcare providers is not to be the condom police. We're supposed to listen to what our patients tell us and use our best knowledge and experience to give them the best options for them and their sexual partners. You want to encourage PrEP for HIV prevention, but you also want to encourage that they adopt or explore other safer sex practices at the same time.

Education on condom use is important in helping to protect individuals from STIs. Providers may only get one chance to build trust and rapport with patients. What you say to them can be life-changing and life-affirming instead of the negative messaging they receive every day.

This is that one person, this is that one moment that they have, and you have an opportunity to either turn them away or help them become more engaged.

Please see full Prescribing Information for DESCOVY FOR PrEP , including BOXED WARNING. References: 1. Ogbuagu O, Ruane PJ, Podzamczer D, et al; the DISCOVER study team. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.

Correction to Lancet HIV ;8 suppl :ee Lancet HIV. Package insert. Gilead Sciences, Inc. Ramgopal M, Ruane P, Shalit P, et al. Poster presented at: IDWeek Virtual Conference; September October 3, Poster Spinner C, Avery A, Flamm JA, et al. Abstract presented at: 11th International AIDS Society IAS Conference on HIV Science; virtual; July , Abstract Correction to Lancet HIV.

Lancet HIV ;8 12 :e Tap for Important Safety Information, including BOXED WARNING about the risk of drug resistance in undiagnosed early HIV-1 infection and post-treatment acute exacerbation of hepatitis B.

You are leaving the DESCOVY FOR PrEP ® website. Proven HIV prevention: Analysis from baseline to over weeks HIV incidence rate: 0.

Participants selected for inclusion had significant risk of acquiring HIV 2,6 Baseline demographics. Median age, years IQR. Black b a. Hispanic or Latino.

Baseline demographics. Baseline HIV risk factors. Rectal gonorrhea, past 24 weeks. Rectal chlamydia, past 24 weeks. Syphilis, past 24 weeks.

Recreational drug use, past 12 weeks. Binge drinking c b. Consider proven HIV prevention data from the largest clinical trial of PrEP. In the United States , Descovy for PrEP ® is indicated to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Descovy has a Boxed Warning in its U. product label regarding the risk of drug resistance when used for PrEP in undiagnosed early HIV infection, and the risk of post-treatment acute exacerbation of hepatitis B.

See below for Indication and Important Safety Information. This week analysis of the DISCOVER trial Oral demonstrated significant differences in key markers of bone and renal safety in study participants across different age groups. These differences were also observed in the overall population, in addition to differences in lipid parameters and change in baseline weight.

The long-term clinical significance of these differences in renal, bone and lipid parameters are not known; however, these measures are important to consider as people at risk increasingly use PrEP for longer periods of time. Key differences favoring Descovy were also observed in markers of proximal tubular function β2-microglobulin:creatinine ratio and retinol binding protein:creatinine ratio.

Among participants with moderate renal impairment, those randomized to Descovy also had smaller changes in eGFR and markers of proximal tubular function.

The analysis also found changes in bone mineral density BMD favoring Descovy in the overall trial population and among participants younger than 25 years of age.

At Week 96 in participants younger than 25 years, spine BMD increased by 1. Hip BMD increased 1. Study participants receiving Descovy had stable lipid levels through 96 weeks, whereas those receiving Truvada had decreases in lipid levels after 48 and 96 weeks.

Fasting glucose levels were similar between the 2 groups. These findings are consistent with the lower lipid levels and decreased weight previously observed with TDF.

This analysis of concomitant hormone therapy on the pharmacokinetics, efficacy and safety profile of Descovy or Truvada builds on the data from the dedicated Phase 1 studies that demonstrated lack of an effect of oral contraceptive hormones on the plasma exposure of TAF, TFV and FTC , and the lack of effect of plasma TAF, TFV, and FTC on ethinyl estradiol exposures, FSH, LH, or progesterone levels.

An analysis of drug levels and adherence in the DISCOVER trial Poster will be presented tomorrow, March The DISCOVER trial is a multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy for PrEP compared with Truvada for PrEP ® in men and transgender women who have sex with men and are at risk for sexually acquired HIV infection.

The primary analysis of the study was at Week 48; the Week 96 analysis was a prespecified secondary analysis. At both Weeks 48 and 96, Descovy for PrEP demonstrated non-inferior efficacy to Truvada for PrEP.

Important U. Safety Information and Indication for Descovy for PrEP. HIV-1—negative status must be confirmed immediately prior to initiation. Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research.


PBS NewsHour full episode, Feb. 12, 2024 Explore with a no-risk trial, past 24 weeks. No-rixk about Triak day q trial. gov Customer Support Questions regarding Grants. Offer Exllore July Demo Center. So if we Affordable menu selections identify the solutions that we need to implement—whether it be destigmatization programs, whether it's HIV testing programs—if we can find out what it takes to make an impact for the people of the South, we can identify what it's gonna take to make an impact on the epidemic across the nation. Press Releases

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