Pre-Exposure Prophylaxis of HIV InfectionPhase 2PURPOSE 5NCT06513312
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
A Phase 2 study testing Lenacapavir Injection, Lenacapavir Tablet and Emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people with Pre-Exposure Prophylaxis of HIV Infection, run by Gilead Sciences at 14 sites in 2 countries.
Trial summary
The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis of HIV Infection
- What is being tested?
- Lenacapavir Injection, Lenacapavir Tablet and Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 7 Oct 2024to Nov 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
- Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people.
- Increased likelihood of HIV acquisition as indicated by at least one of the following:
- Condomless sex with ≥ 2 partners in the past 6 months
- Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months
- Engagement in sex work or transactional sex in the past 12 months
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- Use of ≥ 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in the past 12 months
- Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months
- Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.
- 1) If rapid HIV-1/2 Ab/Ag tests are unavailable due to extenuating circumstances, sites may run a laboratory-instrumented HIV-1/2 Ab/Ag test at their local laboratory, only if they confirm this is a fourth-generation assay and the time from blood draw to injection at any injection visit is < 48 hours.
- Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr):
- (140 - age in years) × (weight in kg) x (0.85 if female) = CLcr (mL/min) / 72 × (serum creatinine in mg/dL)
Who cannot join
- Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation. For cabotegravir, this is defined as 4 weeks since the next injection was due (ie, 12 weeks since their most recent cabotegravir injection).
- Current use of nPEP, unless the prescribed course will be completed prior to randomization.
- Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
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- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding).
- Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United Kingdom8 sites
University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital
Birmingham, B9 5SS
Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 3EW
Axess Sexual Health, Liverpool University Hospitals NHS Trust
Liverpool, L7 8YE
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS Trust
London, E11BB
Homerton Healthcare NHS Foundation Trust, Homerton University Hospital
London, E9 6SR
Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Chelsea and Westminster Hospital NHS Foundation Trust, Clinical Research Facility, Chelsea and Westminster Hospital
London, SW10 9NH
Manchester University NS Foundation Trust
Manchester, M13 0FH
France6 sites
Hopital Avicenne
Bobigny, 93000
Hopital Europeen Marseille
Marseille, 13006
CHU Nice Archet
Nice, 6202
Hopital Saint Louis - Assistance Publique des Hopitaux de Paris
Paris, 75010
APHP Hopital Saint-Antoine
Paris, 75012
APHP Bichat Claude-Bernard Hospital
Paris, 75018
About this study
Official title: A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP
The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).
The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.
- Being tested
- Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenacapavir InjectionDrug
Also called GS-6207, Yeztugo®
Administered subcutaneously
Lenacapavir TabletDrug
Also called GS-6207
Administered orally
Emtricitabine/tenofovir disoproxil fumarate (F/TDF)Drug
Also called Truvada®
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Randomized Phase: Lenacapavir (LEN) Group | Experimental | Participants will receive subcutaneous (SC) LEN 927 mg on Day 1 and 26 weeks and oral LEN 600 mg on Day 1 and 2. Receives: Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet |
| Randomized Phase: F/TDF | Active comparator | Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks. Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) |
| LEN Open Label Extension (OLE) Phase | Experimental | Participants in the F/TDF group will transition to get LEN and participants in the LEN group will continue to get LEN. All participants will get SC LEN on Day 1 and week 26 of the OLE phase. Receives: Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet |
| Pharmacokinetic (PK) Tail Phase: F/TDF | Experimental | After completion of the LEN OLE Phase or upon discontinuation from the Randomized Phase for those receiving LEN, participants will be transitioned to receive F/TDF in the PK Tail Phase. Participants will receive once daily F/TDF for 78 weeks, beginning 26 weeks after the last LEN injection Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks
This outcome measure will compare LEN and F/TDF persistence through 52 weeks, where persistence is defined by On-time LEN Injection at Day 1/Baseline and Week 26 and On-time Follow-up Visit at Week 52 for LEN arm and by Adherence Levels Based on tenofovir diphosphate (TFV-DP) concentrations in red blood cells consistent with ≥ 4 doses/week (≥ 700 fmol/punch) in dried blood spot (DBS) at Weeks 13, 26, 39, and 52 for F/TDF arm.
Measured: Up to Week 52
Secondary outcomes (5)
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: First dose date up to 30 days post last dose at Week 78
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Measured: First dose date up to 30 days post last dose at Week 78
Overall acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with responses to Question on Acceptability
To assess the acceptability of the study drug, participants will complete the questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale with a response of: Completely unacceptable, Unacceptable, No opinion, Acceptable, or Completely acceptable.
Measured: Up to Week 52
Pharmacokinetic (PK) Parameter: Ctrough for LEN at Week 26
Ctrough is defined as the concentration at the end of the dosing interval.
Measured: Week 26
PK Parameter: Ctrough for LEN at Week 52
Ctrough is defined as the concentration at the end of the dosing interval.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start7 Oct 2024
- Primary completion28 May 2026
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure Prophylaxis of HIV InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 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
- NCT06513312
- Sponsor's protocol ID
- GS-US-528-6727
- Other IDs
- 2023-507891-31, 2023
- Acronym
- PURPOSE 5
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP
- ClinicalTrials.gov ID
- NCT06513312
- Acronym / sponsor ID
- PURPOSE 5 / GS-US-528-6727
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Jul 2024 (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 goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).
The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized Phase: Lenacapavir (LEN) Group | Experimental | Drug: Lenacapavir Injection, Drug: Lenacapavir TabletParticipants will receive subcutaneous (SC) LEN 927 mg on Day 1 and 26 weeks and oral LEN 600 mg on Day 1 and 2. |
| Randomized Phase: F/TDF | Active comparator | Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks. |
| LEN Open Label Extension (OLE) Phase | Experimental | Drug: Lenacapavir Injection, Drug: Lenacapavir TabletParticipants in the F/TDF group will transition to get LEN and participants in the LEN group will continue to get LEN. All participants will get SC LEN on Day 1 and week 26 of the OLE phase. |
| Pharmacokinetic (PK) Tail Phase: F/TDF | Experimental | Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)After completion of the LEN OLE Phase or upon discontinuation from the Randomized Phase for those receiving LEN, participants will be transitioned to receive F/TDF in the PK Tail Phase. Participants will receive once daily F/TDF for 78 weeks, beginning 26 weeks after the last LEN injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
- Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people.
- Increased likelihood of HIV acquisition as indicated by at least one of the following:
- Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.
- 1) If rapid HIV-1/2 Ab/Ag tests are unavailable due to extenuating circumstances, sites may run a laboratory-instrumented HIV-1/2 Ab/Ag test at their local laboratory, only if they confirm this is a fourth-generation assay and the time from blood draw to injection at any injection visit is < 48 hours.
Key exclusion criteria (9 listed)
- Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation. For cabotegravir, this is defined as 4 weeks since the next injection was due (ie, 12 weeks since their most recent cabotegravir injection).
- Current use of nPEP, unless the prescribed course will be completed prior to randomization.
- Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
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 InjectionAlso: GS-6207, Yeztugo®Administered subcutaneously | Drug | LEN Open Label Extension (OLE) Phase, Randomized Phase: Lenacapavir (LEN) Group |
| Lenacapavir TabletAlso: GS-6207Administered orally | Drug | LEN Open Label Extension (OLE) Phase, Randomized Phase: Lenacapavir (LEN) Group |
| Emtricitabine/tenofovir disoproxil fumarate (F/TDF)Also: Truvada®Administered orally | Drug | Pharmacokinetic (PK) Tail Phase: F/TDF, Randomized Phase: F/TDF |
Primary outcome
Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks
Time frame: Up to Week 52
This outcome measure will compare LEN and F/TDF persistence through 52 weeks, where persistence is defined by On-time LEN Injection at Day 1/Baseline and Week 26 and On-time Follow-up Visit at Week 52 for LEN arm and by Adherence Levels Based on tenofovir diphosphate (TFV-DP) concentrations in red blood cells consistent with ≥ 4 doses/week (≥ 700 fmol/punch) in dried blood spot (DBS) at Weeks 13, 26, 39, and 52 for F/TDF arm.
5 secondary outcomes
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 30 days post last dose at Week 78
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Time frame: First dose date up to 30 days post last dose at Week 78
Overall acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with responses to Question on Acceptability
Time frame: Up to Week 52
Pharmacokinetic (PK) Parameter: Ctrough for LEN at Week 26
Time frame: Week 26
PK Parameter: Ctrough for LEN at Week 52
Time frame: Week 52
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 15 Jun 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenacapavir Injection, Lenacapavir Tablet and Emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people with Pre-Exposure Prophylaxis of HIV Infection, run by Gilead Sciences at 14 sites in 2 countries.
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 12 inclusion and 9 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks (time frame: Up to Week 52). 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 15 Jun 2026.