With HIV affecting more than one million Americans, it is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we are previewing a selection of clinical trials that are anticipated to complete within the next few years (through December 2028). The clinical trials are all Phase 2 or 3 for HIV pre-exposure prophylaxis (PrEP), in the United States. At the time of this writing, two of the trials selected are still recruiting. Consult the study details and source links for more information regarding the eligibility criteria.

Quick View Table of HIV PrEP Clinical Trials
Study TitlePhaseRecruiting?EnrollmentPrimary CompletionStudy Completion
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)(recruiting; PC: July 2027; SC: July 2027)3Yes4390 (estimated)July 2027 (estimated)July 2027 (estimated)
Study of Lenacapavir and Emtricitabine/​Tenofovir Disoproxil Fumarate (F/​TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) (PURPOSE 3) (PC: July 2026; SC: Jan 2028)2No253July 2026 (estimated)Jan 2028 (estimated)
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (PURPOSE 2)3No3292August 2024August 2028 (estimated)
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) (PURPOSE 365)(recruiting; PC: September 2028; SC: September 2028)3Yes300 (estimated)September 2028 (estimated)September 2028 (estimated)
Study of Lenacapavir and Emtricitabine/​Tenofovir Disoproxil Fumarate (F/​TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (PURPOSE 4) (PC: Dec 2028; SC: Dec 2028)2No181December 2028 (estimated)December 2028 (estimated)
HIV PrEP Clinical Trials in the United States Anticipated to Complete by 2028

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

  • Sponsor: Merck Sharp & Dohme
  • Goals: The goals of this study are to learn if taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day and about the safety of MK-8527 and if people tolerate it.
  • Interventions: MK-8527, FTC/TDF, placebo to MK-8527, placebo to FTC/TDF
  • Primary Outcome Measures: Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection; Number of Participants Who Experience At Least One Adverse Event (AE); Number of Participants Who Discontinue Study Intervention Due to an AE. 
  • Time Frames: Up to approximately two years; Up to approximately two years; Up to approximately two years.
  • Study Details
  • Source

Study of Lenacapavir and Emtricitabine/​Tenofovir Disoproxil Fumarate (F/​TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) (PURPOSE 3)

  • Sponsor: Gilead Sciences
  • Goals: 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.
  • Interventions: Lenacapavir tabled, lenacapavir injection, emtricitabine/tenofovir disoproxil fumarate (F/TDF)
  • Primary Outcome Measures: Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26; PK Parameter: Ctrough for LEN at the End of Week 52; Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs); Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities; General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses; Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses; Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses.
  • Time Frames: Week 26; Week 52; First dose date up to 30 days post last dose at week 78; First dose date up to 30 days post last dose at week 78; Up to week 52; Up to week 52; Up to week 52.
  • Study Details
  • Source

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (PURPOSE 2)

  • Sponsor: Gilead Sciences
  • Goal: The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection.
  • Intervention: Oral lenacapavir (LEN), F/TDF, sub-cutaneous (SC) LEN, placebo SC LEN, PTM F/TDF, PTM Oral LEN, F/TAF (for US participants only)
  • Primary Outcome Measures: Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY); Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set). 
  • Timeframes: Incidence Phase Screening Visit (Day 1); Up to 149 weeks.
  • Study Details
  • Source

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) (PURPOSE 365)

  • Sponsor: Gilead Sciences
  • Goal: 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.
  • Intervention: Lenacapavir injection; lenacapavir tabled.
  • Primary Outcome Measures: Plasma LEN Ctrough at week 52; Percentage of participants experiencing treatment-emergent adverse event (TEAEs); Percentage of participants experiencing treatment-emergent clinical laboratory abnormalities; Percentage of participants with discontinuation due to adverse event.
  • Timeframes: Week 52; First dose up to 30 days post last dose (approximately three years); First dose up to 30 days post last dose (up approximately three years); First dose up to 30 days post last dose (approximately three years).
  • Study Details
  • Source

Study of Lenacapavir and Emtricitabine/​Tenofovir Disoproxil Fumarate (F/​TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (PURPOSE 4)

  • Sponsor: Gilead Sciences
  • Goal: The goals of this clinical study are 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 pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US).
  • Interventions: Lenacapavir injection, lenacapavir tablet, emtricitabine/tenofovir disoproxil fumarate (F/TDF)
  • Primary Outcome Measures: Pharmacokinetic (PK) parameter: ctrough for lenacapavir (LEN): LEN plasma concentration at the end of the dosing interval (week 26); PK parameter: ctrough for LEN: LEN plasma concentration at the end of the dosing interval (week 52); Percentage of participants experiencing treatment-emergent adverse events (TEAEs); Percentage of participants experiencing treatment-emergent clinical laboratory abnormalities with LEN and F/TDF.
  • Timeframes: Week 26; Week 52; First dose date up to 30 days post last dose at week 78; First dose date up to 30 days post last dose at week 78.
  • Study Details
  • Source
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