HIV Pre-exposure ProphylaxisPhase 3PURPOSE 365NCT07047716
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
A Phase 3 study testing Lenacapavir Injection and Lenacapavir Tablet in people with HIV Pre-exposure Prophylaxis, run by Gilead Sciences at 31 sites in United States.
Trial summary
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Pre-exposure Prophylaxis
- What is being tested?
- Lenacapavir Injection and Lenacapavir Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 31 sitesUnited States
- Study dates
- 22 Jul 2025to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 16 years of age at screening.
- Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:
- Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
- For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months
- For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
- Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months
- Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.
Who cannot join
- Current signs or symptoms suggesting HIV infection
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
- Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
- Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
The Hope Clinic of Emory University
Atlanta, Georgia, 30030
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, 30303
Central Texas Clinical Research
Austin, Texas, 78705
Johns Hopkins Hospital - Clinical Research Unit
Baltimore, Maryland, 21287
Be Well Medical Center
Berkley, Michigan, 48072
UAB Sexual Health Research Clinic
Birmingham, Alabama, 35233
Fenway Health
Boston, Massachusetts, 02215
NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)
Chicago, Illinois, 60612
Howard Brown Health Center
Chicago, Illinois, 60613
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
The Crofoot Research Center
Houston, Texas, 77098
UCLA Clinic Care
Los Angeles, California, 90035
Ruane Clinical Research Group, Inc.
Los Angeles, California, 90036
UCLA Vine Street Clinic
Los Angeles, California, 90038
Mills Clinical Research
Los Angeles, California, 90069
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
The ID Prevention Research Unit
Miami, Florida, 33136
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, 06510
University Medical Center
New Orleans, Louisiana, 70119
Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center
New York, New York, 10029
BIOS Clinical Research
Palm Springs, California, 92262
Penn Prevention Unit
Philadelphia, Pennsylvania, 19104
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
Philadelphia, Pennsylvania, 19107
UCSD AntiViral Research Center (AVRC)
San Diego, California, 92103
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington
Seattle, Washington, 98104
University of South Florida - Curran Children's Health Center
Tampa, Florida, 33606
ICAP at Columbia University- Bronx Prevention Center
The Bronx, New York, 10451
Whitman-Walker Institute, Inc.
Washington D.C., District of Columbia, 20009
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP.
The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.
- Conditions
- HIV Pre-exposure Prophylaxis
- Being tested
- Lenacapavir Injection, Lenacapavir Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenacapavir InjectionDrug
Administered intramuscularly
Lenacapavir TabletDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Lenacapavir (LEN) | Experimental | Participants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks:
* LEN 3000 mg injection once on Day 1
* Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period
Participant will receive additional oral LEN if IM injection are not available.
If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks. Receives: Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet |
| LEN Extension Phase | Experimental | Participants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase.
Participants will receive oral LEN if IM injections are not available.
If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks. Receives: Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma LEN Ctrough at Week 52
Ctrough is defined as the concentration at the end of the dosing interval.
Measured: Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Measured: First dose up to 30 days post last dose (approximately 3 years)
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Measured: First dose up to 30 days post last dose (up approximately 3 years)
Percentage of Participants With Discontinuation due to Adverse Event
Measured: First dose up to 30 days post last dose (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start22 Jul 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- It is a single arm study that means all participants will receive LEN. However, the study provides LEN in 2 phases, therefore, the two phases are reported as 2 separate arms.
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047716
- Sponsor's protocol ID
- GS-US-712-7286
- Acronym
- PURPOSE 365
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP
- ClinicalTrials.gov ID
- NCT07047716
- Acronym / sponsor ID
- PURPOSE 365 / GS-US-712-7286
- Conditions
- HIV Pre-exposure Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP.
The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a single arm study that means all participants will receive LEN. However, the study provides LEN in 2 phases, therefore, the two phases are reported as 2 separate arms.
| Arm | Type | Receives |
|---|---|---|
| Lenacapavir (LEN) | Experimental | Drug: Lenacapavir Injection, Drug: Lenacapavir TabletParticipants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks: * LEN 3000 mg injection once on Day 1 * Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period Participant will receive additional oral LEN if IM injection are not available. If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks. |
| LEN Extension Phase | Experimental | Drug: Lenacapavir Injection, Drug: Lenacapavir TabletParticipants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase. Participants will receive oral LEN if IM injections are not available. If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- At least 16 years of age at screening.
- Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:
- Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.
Key exclusion criteria (6 listed)
- Current signs or symptoms suggesting HIV infection
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
- Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
- Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenacapavir InjectionAdministered intramuscularly | Drug | LEN Extension Phase, Lenacapavir (LEN) |
| Lenacapavir TabletAdministered orally | Drug | LEN Extension Phase, Lenacapavir (LEN) |
Primary outcome
Plasma LEN Ctrough at Week 52
Time frame: Week 52
Ctrough is defined as the concentration at the end of the dosing interval.
Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Time frame: First dose up to 30 days post last dose (approximately 3 years)
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (up approximately 3 years)
Percentage of Participants With Discontinuation due to Adverse Event
Time frame: First dose up to 30 days post last dose (approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for HIV Pre-exposure Prophylaxis
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenacapavir Injection and Lenacapavir Tablet in people with HIV Pre-exposure Prophylaxis, run by Gilead Sciences at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma LEN Ctrough at Week 52 (time frame: Week 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.