Clinical trial NCT06101329: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pre-Exposure Prophylaxis of HIV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: HIV Prevention Trials Network
First posted: 2023-10-26
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26
timeFrame: Week 26
measure: PK Parameter: Ctrough for LEN at the End of Week 52
timeFrame: Week 52
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 30 days post last dose at Week 78
measure: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
timeFrame: First dose date up to 30 days post last dose at Week 78
measure: General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
timeFrame: Up to Week 52
measure: Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses
timeFrame: Up to Week 52
measure: Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses
timeFrame: Up to Week 52
Secondary outcomes:
measure: Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received
timeFrame: Up to Week 26
measure: Number of Participants with Adherence to F/TDF, as Assessed by Adherence Levels Based on Tenofovir diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)
timeFrame: Up to Week 78
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB, 1917 Research Clinic
state: Alabama
city: San Diego
country: United States
facility: UCSD Antiviral Research Center (AVRC)
state: California
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Atlanta
country: United States
facility: Ponce de Leon Center Clinical Research Site
state: Georgia
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
city: Newark
country: United States
facility: Rutgers New Jesey Medical School - Clinical Research Center
state: New Jersey
city: Bronx
country: United States
facility: ICAP at Columbia University - Bronx Prevention Center
state: New York
city: New York
country: United States
facility: Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Harlem Prevention Center CRS
state: New York
city: Chapel Hill
country: United States
facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Penn Prevention Research Unit
state: Pennsylvania
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: