An observational study in HIV Infections, sponsored by Gilead Sciences. Recruiting at 44 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Gilead Sciences · Observational
Among 84 studies in HIV Infections by Gilead Sciences — 2 open to participants now, 8 under way, 4 of them phase 3. HIV Infections · Gilead Sciences.
Among the 84 studies in HIV Infections by Gilead Sciences, this one is one of 2 that started in 2026, is one of 5 observational ones, and was the 83rd registered.
4,735 studies on the registry are indexed under HIV Infections; 245 are open to participants now.
Browse HIV Infections studies →2 of the 84 studies in HIV Infections by Gilead Sciences are open now, in 3 countries. Recruiting first, the newest first:
Gilead Sciences · Sites in United States, Australia, Japan
Ages 18+
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
84 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 21 · Phase 3 30 · Phase 4 12
First in 1999; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 3,000 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Median enrollment 131 across the 72 interventional studies, 476 across the 5 observational. Of the 71 that completed or were terminated, 28 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
Gilead Sciences is the lead sponsor of 692 studies on the registry; 26 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 84 studies in HIV Infections by Gilead Sciences, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.
The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.
People who need or want HIV prevention services identified and engaged through routine clinical practice
Key Inclusion Criteria:
After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Participants in diverse clinical settings in the United States (US) who choose subcutaneous (SC) Lenacapavir (LEN) Pre-Exposure Prophylaxis for HIV Prevention (PrEP) at enrollment in the study or anytime during the follow-up period
Drug: Lenacapavir Injection · Drug: Lenacapavir Tablet
Participants in diverse clinical settings in the United States (US) who choose other PrEP options ( F/TDF, F/TAF, CAB) or No PrEP.
Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) · Drug: Emtricitabine/tenofovir alafenamide (F/TAF) · Drug: Cabotegravir (CAB)
Administered via subcutaneous (SC) injection
Also known as: YEZTUGO®
Tablets administered orally
Also known as: Truvada®
Drug page: Emtricitabine tenofovir alafenamide
Tablets administered orally
Also known as: Descovy®
Administered via intramuscular (IM) injection
Also known as: CAB
Administered orally
Proportion of Participants with LEN PrEP Persistence at Week 52
LEN PrEP persistence at Week 52 is defined as the proportion of participants receiving a LEN injection at enrollment who had an on-time injection at Week 26 and an on-time Week 52 visit ('on time' is defined as ≤ 28 weeks from the last injection).
Time frame: Week 52
Uptake of PrEP: Proportion of Participants Who Decided to Use PrEP at Enrollment (Baseline) and Different Types of PrEP
Time frame: Baselines (Day 1, date of the first LEN/CAB injection or oral PrEP prescription)
PrEP Persistence: Proportion of Participants who Persistently Used PrEP at Weeks 26, 78 and 104, Overall and by PrEP Type
Time frame: Up to Week 104
PrEP Coverage: Proportion of Days Protected by PrEP at Weeks 26, 52, 78, and 104, Overall and by PrEP Type
Time frame: Up to Week 104
PrEP Persistence: Mean Duration of PrEP Use
Time frame: Up to Week 104
PrEP Continuation: Proportion of Participants who Continued to Use PrEP at Week 26, 52, 78, and 104, Overall and Specific Types of PrEP
Time frame: Up to Week 104
PrEP Interruptions Assessed by Proportion of Participants who Adopted/Continued PrEP at Enrollment and Experienced Interruptions at Different Time Points at Week 26, 52, 78, and 104
Time frame: Up to Week 104
PrEP Interruptions Assessed by Proportion of Participants who Needed one or More LEN PrEP Re-initiations who Adopted/Continued LEN PrEP at Enrollment, at Week 26, 52, 78, and 104
Time frame: Up to Week 104
PrEP Interruptions Assessed by Time Between Injections for Participants Initiating LEN PrEP who had to Re-initiate LEN PrEP
Time frame: Week 26, Week 52, Week 78, and Week 104
Switching (Any Switch): Proportion of Participants Who Use any PrEP Method Different from the PrEP Method Adopted/Continued at Enrollment, at Weeks 26, 52, 78, and 104
Time frame: Week 26, Week 52, Week 78, and Week 104
Switch (Switch to LEN PreP): Proportion of Participants Switching to LEN PrEP among Participants who did not Initiate LEN PrEP at Enrollment, at Weeks 26, 52, 78, and 104
Time frame: Week 26, Week 52, Week 78, and Week 104
Time to First LEN Injection: Days From Enrollment and Choice of LEN PrEP to First Dose of LEN Injection as PrEP
Time frame: Up to Week 104
Proportion of Participants with Receipt of First LEN PrEP Injection on the Same Day as Enrollment in the Study
Time frame: Enrollment up to Week 104
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for Apr 2028, 25 months after the start.
Of 201 observational studies under HIV Infections, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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