Clinical Trials for People Living with HIV

Clinical Trials (Updated April 2026)

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
https://clinicaltrials.gov/study/NCT07044297

Study Contact:
Name: Toll Free Number
Phone Number: 1-888-577-8839
Email: Trialsites@msd.com

Optimizing Tobacco Use Treatment for PLWHA (HTO)
https://clinicaltrials.gov/study/NCT04176172

Study Contact:
Name: Robert Schnoll, PhD
Phone Number: 215-746-7143
Email: schnoll@pennmedicine.upenn.edu

Improving the Organizational Social Context to Address Structural Racism and Discrimination
https://clinicaltrials.gov/study/NCT06462807

Study Contact:
Name: Florence Momplaisir
Phone Number: 215-746-7143
Email: florence.momplaisir@pennmedicine.upenn.edu

Ongoing Clinical Trials

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
Trial Number: GS-US-712-7286

Description: 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

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who are Successfully Treated With a Complicated Regimen
Trial Number: GS-US-621-6289

Description: An operationally seamless Phase 2/3 randomized, open-label, multicenter, active-controlled study to evaluate the safety and efficacy of bictregravir/lenacapavir versus stable baseline regimen in virologically suppressed people with HIV-1 on stable complex treatment regimens

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Trial Number: GS-US-621-6290

Description: A phase 3 double-blind multicenter randomized active-controlled study to evaluate the safety and efficacy of bictegravir/lenacapavir versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in virologically suppressed people with HIV-1

Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir (LEN) for HIV Pre-Exposure Prophylaxis (PrEP)
Trial Number: GS-US-528-9023

Description: A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection

Acceptability of Long-Acting Injectable Lenacapavir (LEN) Versus Oral Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for HIV Pre-Exposure Prophylaxis (PrEP): Qualitative Insights Into Social and Behavioral Contexts
Trial Number: GS-US-528-6364

Description: A Qualitative Study for participants already enrolled in GS-US-528-9023 to examine Acceptability of Long-Acting Injectable Lenacapavir Versus Oral Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Nonbinary People