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

Description

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.

Conditions

Pre-Exposure Prophylaxis of HIV Infection

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pre-Exposure Prophylaxis of HIV Infection
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB, 1917 Research Clinic, Birmingham, Alabama, United States, 35222

San Diego

UCSD Antiviral Research Center (AVRC), San Diego, California, United States, 92103

Atlanta

Ponce de Leon Center Clinical Research Site, Atlanta, Georgia, United States, 30303

Boston

Fenway Health, Boston, Massachusetts, United States, 02215

Newark

Rutgers New Jesey Medical School - Clinical Research Center, Newark, New Jersey, United States, 07103

Bronx

ICAP at Columbia University - Bronx Prevention Center, Bronx, New York, United States, 10451

New York

Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine, New York, New York, United States, 10010

New York

Harlem Prevention Center CRS, New York, New York, United States, 10027

Chapel Hill

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Philadelphia

Penn Prevention Research Unit, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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):
  • * 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).
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2028-10