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NCT06101329 | RECRUITING | Pre-Exposure Prophylaxis of HIV Infection

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

Gilead Sciences

Brief 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. 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.

Condition or disease

Pre-Exposure Prophylaxis of HIV Infection

Intervention/treatment

Lenacapavir Tablet

Lenacapavir Injection

Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 250 participants
Masking : NONE
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2023-11-17
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2028-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

Location Details

NCT06101329

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

UAB, 1917 Research Clinic

Birmingham, Albama, United States, 35222

RECRUITING

United States, California

UCSD Antiviral Research Center (AVRC)

San Diego, California, United States, 92103

RECRUITING

United States, District of Columbia

George Washington University Medical Faculty Associates

Washington, District of Columbia, United States, 20037

RECRUITING

United States, Georgia

Ponce de Leon Center Clinical Research Site

Atlanta, Georgia, United States, 30303

RECRUITING

United States, Massachusetts

Fenway Health

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New Jersey

Rutgers New Jesey Medical School - Clinical Research Center

Newark, New Jersey, United States, 07103

RECRUITING

United States, New York

ICAP at Columbia University - Bronx Prevention Center

Bronx, New York, United States, 10451

RECRUITING

United States, New York

Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, United States, 10010

RECRUITING

United States, New York

Harlem Prevention Center CRS

New York, New York, United States, 10027

RECRUITING

United States, North Carolina

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, Pennsylvania

Penn Prevention Research Unit

Philadelphia, Pennsylvania, United States, 19104