Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) (PURPOSE 3)

• ClinicalTrials.gov Identifier: NCT06101329
• Recruitment Status: Recruiting
• First Posted: October 26, 2023
• Last Update Posted: May 3, 2024
• Sponsor: Gilead Sciences
• Collaborator: HIV Prevention Trials Network
• Information provided by (Responsible Party): Gilead Sciences

Tracking Information

• First Submitted Date: October 20, 2023
• First Posted Date: October 26, 2023
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: November 17, 2023
• Estimated Primary Completion Date: January 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2023)

• Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26 [ Time Frame: Week 26 ]
  Ctrough is defined as the concentration at the end of the dosing interval.
• PK Parameter: Ctrough for LEN at the End of Week 52 [ Time Frame: Week 52 ]
  Ctrough is defined as the concentration at the end of the dosing interval.
• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 30 days post last dose at Week 78 ]
• Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 30 days post last dose at Week 78 ]
• General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses [ Time Frame: Up to Week 52 ]
  To assess the acceptability of the study drug, participants will complete the questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale with a response of: Completely unacceptable, Unacceptable, No opinion, Acceptable, or Completely acceptable.
• Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses [ Time Frame: Up to Week 52 ]
  To assess the satisfaction with use of the study drug, participants will complete the questionnaire including a question on satisfaction with use of the assigned study drug on an ordinal 5-category scale with a response of: Very satisfied, Satisfied, Neutral, Dissatisfied, or Very dissatisfied.
• Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses [ Time Frame: Up to Week 52 ]
  To assess the willingness to use the study drug, participants will complete the questionnaire including a question on willingness to use the assigned study drug on an ordinal 5-category scale with a response of: Definitely Yes, Probably yes, Not sure/undecided, Probably No, or Definitely No.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 20, 2023)

• Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received [ Time Frame: Up to Week 26 ]
• 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) [ Time Frame: Up to Week 78 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Pre-Exposure Prophylaxis of HIV Infection

Intervention

• Drug: Lenacapavir Tablet
  Tablets administered orally without regard of food
  Other Name: GS-6207
• Drug: Lenacapavir Injection
  Injection administered subcutaneously
  Other Name: GS-6207
• Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
  200/300mg fixed dose combination (FDC) tablets administered orally
  Other Name: Truvada®

Study Arms

• Experimental: Randomized Phase: Lenacapavir (LEN) Group
  Participants will receive subcutaneous (SC) lenacapavir (LEN) 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.
  Interventions:

  • Drug: Lenacapavir Tablet
  • Drug: Lenacapavir Injection
• Experimental: Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group
  Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks.
  Intervention: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
• Experimental: PK Tail Phase: F/TDF
  After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF and participants in F/TDF group will continue to receive F/TDF in the PK Tail Phase. All participants will receive F/TDF, once daily for 78 weeks beginning 26 weeks after the last LEN injection.
  Intervention: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 20, 2023): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2028
• Estimated Primary Completion Date: January 2028 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Gilead Clinical Study Information Center; 1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06101329
• Other Study ID Numbers: GS-US-528-6020
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gilead Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Gilead Sciences
• Original Study Sponsor: Same as current
• Collaborators: HIV Prevention Trials Network

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

• PRS Account: Gilead Sciences
• Verification Date: May 2024