A Phase 3 interventional study of TDF/FTC 300mg/200mg fixed-dose combination tablets and TAF/FTC 25mg/200mg fixed-dose combination tablets in HIV/AIDS, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 6 sites in 2 countries. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment
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Among 10 studies in Acquired Immunodeficiency Syndrome by ANRS, Emerging Infectious Diseases — 3 open to participants now, 3 under way, 1 of them phase 3. Acquired Immunodeficiency Syndrome · ANRS, Emerging Infectious Diseases.
Among the 10 studies in Acquired Immunodeficiency Syndrome by ANRS, Emerging Infectious Diseases, this one is one of 3 that started in 2024, is one of 2 in phase 3, and was the 8th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →3 of the 10 studies in Acquired Immunodeficiency Syndrome by ANRS, Emerging Infectious Diseases are open now, in 2 countries. Recruiting first, the newest first:
ANRS, Emerging Infectious Diseases · Sites in France
Ages 18–70
ANRS, Emerging Infectious Diseases
Ages 18+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · male · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 524 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 69 across the 7 interventional studies, 224 across the 3 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
1 of the studies in Acquired Immunodeficiency Syndrome by ANRS, Emerging Infectious Diseases that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05300035ANRS, Emerging Infectious DiseasesPhase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control | 2026-12-10 |
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Among the 10 studies in Acquired Immunodeficiency Syndrome by ANRS, Emerging Infectious Diseases, from their registry updates:
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The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF/FTC in HIV-uninfected cisgender men who have sex with men (MSM).
Primary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.
The study will enroll HIV-uninfected MSM at risk for acquiring HIV infection. Participants will be enrolled over 2 years and followed up until the closure of the clinical study. Therefore, the follow up duration will be up to 3 years for first enrollees and up to1 year for the last enrollee. The study will be implemented in Thailand (60% of participants) and France (40%).
Participants will be randomly assigned to one of two regimens:
Participants will attend up to 15 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, and swabs collection (oral and rectal). At the end of their study participation, all participants will be transitioned to locally available HIV prevention services, including PrEP.
Inclusion Criteria:
Non-inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills.
Drug: TDF/FTC 300mg/200mg fixed-dose combination tablets
Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later.
Drug: TAF/FTC 25mg/200mg fixed-dose combination tablets
Event-driven dosing regimen
Also known as: Truvada
Drug page: Emtricitabine tenofovir alafenamide
Event-driven dosing regimen.
Also known as: Descovy
Efficacy of F/TAF
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TAF arm.
Time frame: All along the study
Efficacy of F/TDF
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TDF arm.
Time frame: All along the study
Acceptability of F/TAF versus F/TDF
Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.
Time frame: At 1 and at 2 years of follow up.
Safety of F/TAF versus F/TDF
1. Numbers of participants experiencing, through study completion (an average of 2 years): * at least one Grade 3 or 4 treatment-related adverse event as graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events \[Corrected Version 2.1 July 2017\], * at least one serious adverse event as graded using the same tables. 2. Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years. 3. Change from baseline in body weight at 1, 2, and 3 years.
Time frame: All along the study
Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 42 months after the start.
Of 31 non-industry phase 3 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 51. This study's planned 42 months is above that.
Counting every sponsor, half of 65 studies reached it within 26 months; a quarter within 19 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Emtricitabine tenofovir alafenamide
Acquired Immunodeficiency Syndrome →
ANRS, Emerging Infectious Diseases →