Evaluating Lenacapavir and Emtricitabine/Tenofovir for HIV Prevention in Women

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

This study is testing if a new HIV prevention method using lenacapavir injections and a pill called emtricitabine/tenofovir is safe and acceptable for women in the U.S.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Gilead Sciences (Industry-sponsored)
• Locations: 11 sites (Birmingham, Alabama and 10 other locations)
• Trial ID: NCT06101329 on ClinicalTrials.gov

What this trial studies

This clinical study aims to investigate how lenacapavir (LEN) is processed in the body and assess the safety of LEN combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) for preventing HIV in cisgender women in the United States. The study will characterize the pharmacokinetics of LEN, evaluate the safety of both LEN and F/TDF as pre-exposure prophylaxis (PrEP), and assess the acceptability of LEN injections and oral F/TDF among participants. The study is interventional and is conducted in various locations across the U.S.

Who should consider this trial

Good fit: Ideal candidates for this study are cisgender women who have engaged in condomless vaginal or anal sex with cisgender men in the past year.

Not a fit: Patients who are not at risk for HIV or those who do not meet the inclusion criteria, such as being HBsAg positive, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective option for HIV prevention in cisgender women.

How similar studies have performed: Other studies have shown success with similar approaches in HIV prevention, indicating a promising avenue for further exploration.

Eligibility criteria

Key Inclusion Criteria:

* 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).

Key Exclusion Criteria:

* 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.

Where this trial is running

Birmingham, Alabama and 10 other locations

• UAB, 1917 Research Clinic — Birmingham, Alabama, United States (Recruiting)
• UCSD Antiviral Research Center (AVRC) — San Diego, California, United States (Recruiting)
• George Washington University Medical Faculty Associates — Washington, District of Columbia, United States (Recruiting)
• Ponce de Leon Center Clinical Research Site — Atlanta, Georgia, United States (Recruiting)
• Fenway Health — Boston, Massachusetts, United States (Recruiting)
• Rutgers New Jesey Medical School - Clinical Research Center — Newark, New Jersey, United States (Recruiting)
• ICAP at Columbia University - Bronx Prevention Center — Bronx, New York, United States (Recruiting)
• Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine — New York, New York, United States (Recruiting)
• Harlem Prevention Center CRS — New York, New York, United States (Recruiting)
• NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
• Penn Prevention Research Unit — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions Pre-Exposure Prophylaxis of HIV Infection