Pre-Exposure Prophylaxis of HIV InfectionPhase 2PURPOSE 3NCT06101329
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
A Phase 2 study testing Lenacapavir Tablet, Lenacapavir Injection and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in people with Pre-Exposure Prophylaxis of HIV Infection, run by Gilead Sciences at 11 sites in United States.
Trial summary
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis of HIV Infection
- What is being tested?
- Lenacapavir Tablet, Lenacapavir Injection 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
- 253 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Nov 2023to Jan 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.
- Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
- Self-report one or more of the following in the past 12 months (except for incarceration, which could have occurred in the past 5 years):
- 1) Noninjection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those prescribed by a licensed provider); 2) Alcohol dependence (defined as Cut Down, Annoyed, Guilty, and Eye Opener score of 2); binge-drinking, defined as 4 or more drinks at a time; 3) History of STIs, such as gonorrhea, chlamydia, or syphilis; 4) Exchange of sex for commodities, such as drugs, money, or shelter; 5) Incarceration (jail or prison > 24 hours within the past 5 years); 6) Two or more sexual partners who were assigned male at birth; 7) Sexual partner assigned male at birth with history of either injection or noninjection recreational drug use, sexually transmitted infections (STIs), human immunodeficiency virus (HIV) diagnosis or unknown HIV status, additional sex partners during the course of his sexual relationship with the individual, or incarceration (jail or prison > 24 hours within the past 5 years)
- 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).
- Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
Who cannot join
- Self-reported history of previous positive results on an HIV test.
- One or more reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
- Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).
- Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).
- Acute viral hepatitis A or acute or chronic hepatitis B or C infection.
- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding, etc).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, 30303
UAB, 1917 Research Clinic
Birmingham, Alabama, 35222
Fenway Health
Boston, Massachusetts, 02215
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, 10010
Harlem Prevention Center CRS
New York, New York, 10027
Rutgers New Jesey Medical School - Clinical Research Center
Newark, New Jersey, 07103
Penn Prevention Research Unit
Philadelphia, Pennsylvania, 19104
UCSD Antiviral Research Center (AVRC)
San Diego, California, 92103
ICAP at Columbia University - Bronx Prevention Center
The Bronx, New York, 10451
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US.
The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
- Being tested
- Lenacapavir Tablet, Lenacapavir Injection, 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 TabletDrug
Also called GS-6207
Tablets administered orally without regard of food
Lenacapavir InjectionDrug
Also called GS-6207, Yeztugo®
Injection administered subcutaneously
Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)Drug
Also called Truvada®
200/300mg fixed dose combination (FDC) tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Randomized Phase: Lenacapavir (LEN) Group | Experimental | Participants will receive subcutaneous (SC) lenacapavir (LEN) 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2. Receives: Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group | Experimental | Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks. Receives: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) |
| PK Tail Phase: F/TDF | Experimental | After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF and participants in F/TDF group will continue to receive F/TDF in the PK Tail Phase. All participants will receive F/TDF, once daily 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.
Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26
Ctrough is defined as the concentration at the end of the dosing interval.
Measured: Week 26
PK Parameter: Ctrough for LEN at the End of 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 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
General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
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
Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses
To assess the satisfaction with use of the study drug, participants will complete the questionnaire including a question on satisfaction with use of the assigned study drug on an ordinal 5-category scale with a response of: Very satisfied, Satisfied, Neutral, Dissatisfied, or Very dissatisfied.
Measured: Up to Week 52
Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses
To assess the willingness to use the study drug, participants will complete the questionnaire including a question on willingness to use the assigned study drug on an ordinal 5-category scale with a response of: Definitely Yes, Probably yes, Not sure/undecided, Probably No, or Definitely No.
Measured: Up to Week 52
Secondary outcomes (2)
Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received
Measured: Up to Week 26
Number of Participants with Adherence to F/TDF, as Assessed by Adherence Levels Based on Tenofovir diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)
Measured: Up to Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start17 Nov 2023
- Primary completion22 Jul 2026
- Study completionJan 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HIV Prevention Trials Network
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101329
- Sponsor's protocol ID
- GS-US-528-6020
- Acronym
- PURPOSE 3
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2023
- Last updated
- 17 Aug 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 17 Aug 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 Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States
- ClinicalTrials.gov ID
- NCT06101329
- Acronym / sponsor ID
- PURPOSE 3 / GS-US-528-6020
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- HIV Prevention Trials Network
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Oct 2023 (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 look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US.
The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized Phase: Lenacapavir (LEN) Group | Experimental | Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionParticipants will receive subcutaneous (SC) lenacapavir (LEN) 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2. |
| Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group | Experimental | Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks. |
| PK Tail Phase: F/TDF | Experimental | Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF and participants in F/TDF group will continue to receive F/TDF in the PK Tail Phase. All participants will receive F/TDF, once daily for 78 weeks beginning 26 weeks after the last LEN injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.
- Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
- Self-report one or more of the following in the past 12 months (except for incarceration, which could have occurred in the past 5 years):
- 1) Noninjection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those prescribed by a licensed provider); 2) Alcohol dependence (defined as Cut Down, Annoyed, Guilty, and Eye Opener score of 2); binge-drinking, defined as 4 or more drinks at a time; 3) History of STIs, such as gonorrhea, chlamydia, or syphilis; 4) Exchange of sex for commodities, such as drugs, money, or shelter; 5) Incarceration (jail or prison > 24 hours within the past 5 years); 6) Two or more sexual partners who were assigned male at birth; 7) Sexual partner assigned male at birth with history of either injection or noninjection recreational drug use, sexually transmitted infections (STIs), human immunodeficiency virus (HIV) diagnosis or unknown HIV status, additional sex partners during the course of his sexual relationship with the individual, or incarceration (jail or prison > 24 hours within the past 5 years)
- 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).
Key exclusion criteria (7 listed)
- Self-reported history of previous positive results on an HIV test.
- One or more reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
- Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).
- Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).
- Acute viral hepatitis A or acute or chronic hepatitis B or C infection.
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 TabletAlso: GS-6207Tablets administered orally without regard of food | Drug | Randomized Phase: Lenacapavir (LEN) Group |
| Lenacapavir InjectionAlso: GS-6207, Yeztugo®Injection administered subcutaneously | Drug | Randomized Phase: Lenacapavir (LEN) Group |
| Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)Also: Truvada®200/300mg fixed dose combination (FDC) tablets administered orally | Drug | PK Tail Phase: F/TDF, Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group |
Primary outcome
Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26
Time frame: Week 26
Ctrough is defined as the concentration at the end of the dosing interval.
PK Parameter: Ctrough for LEN at the End of 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 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
General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
Time frame: Up to Week 52
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.
Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses
Time frame: Up to Week 52
To assess the satisfaction with use of the study drug, participants will complete the questionnaire including a question on satisfaction with use of the assigned study drug on an ordinal 5-category scale with a response of: Very satisfied, Satisfied, Neutral, Dissatisfied, or Very dissatisfied.
Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses
Time frame: Up to Week 52
To assess the willingness to use the study drug, participants will complete the questionnaire including a question on willingness to use the assigned study drug on an ordinal 5-category scale with a response of: Definitely Yes, Probably yes, Not sure/undecided, Probably No, or Definitely No.
2 secondary outcomes
Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received
Time frame: Up to Week 26
Number of Participants with Adherence to F/TDF, as Assessed by Adherence Levels Based on Tenofovir diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)
Time frame: Up to Week 78
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 17 Aug 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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenacapavir Tablet, Lenacapavir Injection and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in people with Pre-Exposure Prophylaxis of HIV Infection, run by Gilead Sciences at 11 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 6 inclusion and 7 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 17 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 11 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 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?
Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26 (time frame: Week 26). The study lists 7 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 17 Aug 2026.