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

Study Description

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	Intervention/treatment	Phase
Pre-Exposure Prophylaxis of HIV Infection	Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection; Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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: November 17, 2023
• Estimated Primary Completion Date: January 2028
• Estimated Study Completion Date: January 2028

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Lenacapavir Tablet; Tablets administered orally without regard of food; Other Name: GS-6207; Drug: Lenacapavir Injection; Injection administered subcutaneously; Other Name: GS-6207
Experimental: Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group; Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks.	Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF); 200/300mg fixed dose combination (FDC) tablets administered orally; Other Name: Truvada®
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.	Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF); 200/300mg fixed dose combination (FDC) tablets administered orally; Other Name: Truvada®

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 30 days post last dose at Week 78 ]
4. Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 30 days post last dose at Week 78 ]
5. 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.
6. 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.
7. 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.

Secondary Outcome Measures :

1. Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received [ Time Frame: Up to Week 26 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

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

Locations

United States, California

UCSD Antiviral Research Center (AVRC); Recruiting

San Diego, California, United States, 92103

Sponsors and Collaborators

Gilead Sciences

HIV Prevention Trials Network

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

More Information

Additional Information:

Gilead Clinical Trials Website 

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT06101329
• Other Study ID Numbers: GS-US-528-6020
• First Posted: October 26, 2023
• Last Update Posted: May 3, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Antiviral Agents; Anti-Infective Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents