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Antiviral

F/TAF for HIV Pre-Exposure Prophylaxis (DISCOVER Trial)

Phase 3

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate liver and hematologic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up when all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)

Awards & highlights

DISCOVER Trial Summary

This trial is testing whether a daily pill regimen of either emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil fumarate can help prevent HIV-1 infection in Men who have sex with men and transgender women.

Who is the study for?

This trial is for men and transgender women who have sex with men, are at high risk of HIV-1 infection, and have had recent sexually transmitted infections or unprotected intercourse. Participants must be HIV negative with adequate blood cell counts, kidney function (eGFR ≥ 60 mL/min), liver function (AST/ALT ≤ 2.5 × ULN), and not have serious proteinuria or glycosuria.Check my eligibility

What is being tested?

The study compares the effectiveness of two daily pre-exposure prophylaxis treatments to prevent HIV: Emtricitabine/Tenofovir Alafenamide (F/TAF) versus Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF). Participants will be followed for a minimum of 48 weeks, with half being monitored for up to 96 weeks after starting treatment.See study design

What are the potential side effects?

Possible side effects include digestive issues like nausea or diarrhea, headaches, fatigue, skin rashes, and changes in bone density or kidney function. These medications can also affect liver enzymes and may cause other less common side effects.

DISCOVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver functions, including AST, ALT, and bilirubin levels, are within normal ranges.

Select...

I've had unprotected sex with at least two men whose HIV status I don't fully know in the last 3 months.

Select...

My kidneys work well, with a filtration rate of 60 mL/min or more.

DISCOVER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and when all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV Infections

Secondary outcome measures

Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase

Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase

HIV Infections

+12 more

Side effects data

From 2021 Phase 3 trial • 567 Patients • NCT03110380

15%

Nasopharyngitis

12%

Upper respiratory tract infection

Diarrhoea

Fatigue

Arthralgia

Back pain

Influenza

Insomnia

Sinusitis

Headache

Bronchitis

Pain in extremity

Hypertension

Cough

Rash

Dyspnoea

Drug abuse

Coronary artery disease

Diverticulitis

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Treatment Phase B/F/TAF

Double-Blind Treatment Phase DTG + F/TAF

Open-label Extension Phase B/F/TAF From B/F/TAF

Open-label Extension Phase B/F/TAF From DTG + F/TAF

DISCOVER Trial Design

4Treatment groups

Experimental Treatment

Group I: Open-labelExperimental Treatment1 Intervention

Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment for 96 weeks.

Group II: Open-Label ExtensionExperimental Treatment1 Intervention

Participants who remain on study at Open-label Week 96 will have the option to continue on open-label F/TAF treatment in the Open-label extension phase for 408 weeks.

Group III: F/TDFExperimental Treatment2 Interventions

F/TDF+ F/TAF placebo for at least 96 weeks

Group IV: F/TAFExperimental Treatment2 Interventions

F/TAF+ F/TDF placebo for at least 96 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

F/TAF

2019

Completed Phase 3

~2770

F/TDF

2018

Completed Phase 3

~250

F/TAF Placebo

2017

Completed Phase 3

~2460

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

842,863 Total Patients Enrolled

1 Trials studying Pre-Exposure Prophylaxis

57 Patients Enrolled for Pre-Exposure Prophylaxis

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

181,294 Total Patients Enrolled

Media Library

Emtricitabine (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT02842086 — Phase 3

Pre-Exposure Prophylaxis Research Study Groups: F/TAF, F/TDF, Open-label, Open-Label Extension

Pre-Exposure Prophylaxis Clinical Trial 2023: Emtricitabine Highlights & Side Effects. Trial Name: NCT02842086 — Phase 3

Emtricitabine (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02842086 — Phase 3

Pre-Exposure Prophylaxis Patient Testimony for trial: Trial Name: NCT02842086 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still taking people for this test?

"Unfortunately, this study has already stopped recruiting new patients. The trial was first posted on September 2nd, 2016 and was last updated on June 28th, 2022. However, there are plenty of other clinical trials that may be of interest; there are currently 1212 studies for infections and 125 for F/TAF actively looking for participants."

Answered by AI

From how many different physical locations is this trial being overseen?

"To make participating in this trial as convenient as possible for volunteers, recruitment is taking place at 45 different locations. These include places like Macon, Beverly Hills, and Orlando."

Answered by AI

Are there any other notable investigations that have looked at F/TAF?

"As of now, there are 125 F/TAF clinical trials taking place with 31 of them in Phase 3. Even though a great many of the F/TAF studies are based in Boylston, Massachusetts, there are actually 1,729 total locations running clinical trials for the medication."

Answered by AI

What are the common applications for F/TAF?

"F/TAF is most commonly used to treat treatment naive patients, however it can also be given to other individuals including those that weigh at least 40 kg, have no resistance to darunavir, and are human immunodeficiency virus type 1 (hiv-1) positive."

Answered by AI

What are the odds of developing negative side effects from taking F/TAF?

"F/TAF has received a 3 for safety from our team at Power. That's because this is a Phase 3 trial, which means that, in addition to data supporting efficacy, there is also multiple rounds of data supporting safety."

Answered by AI