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Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PURPOSE 2)

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ClinicalTrials.gov Identifier: NCT04925752
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE May 28, 2021
First Posted Date  ICMJE June 14, 2021
Last Update Posted Date July 26, 2022
Actual Study Start Date  ICMJE June 28, 2021
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY) [ Time Frame: At Screening ]
  • Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up [ Time Frame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY) [ Time Frame: At Screening ]
  • Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up [ Time Frame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • HIV Incidence Among Participants While Adherent to Study Drug [ Time Frame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
  • Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • HIV Incidence Among Participants While Adherent to Study Drug [ Time Frame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
  • Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis
Official Title  ICMJE A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection
Brief Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) - 1 infection relative to the background HIV-1 incidence rate.

The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a double-blind, randomized study (Randomized Phase). The Incidence Phase will include initial assessments that will provide an estimate of the concurrent background HIV-1 incidence rate. The Randomized Phase of the study will have a Blinded Phase, a LEN Open-label Extension (OLE) Phase, and a pharmacokinetic (PK) Tail Phase.

The primary objective for the Incidence Phase of this study is to estimate the HIV-1 background incidence rate. The primary objective of the Randomized Blinded Phase of this study is to evaluate the efficacy of lenacapavir for HIV-1 pre-exposure prophylaxis (PrEP) in cisgender men (CGM), transgender women (TGW), transgender men (TGM), and gender nonbinary people (GNB) ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pre-Exposure Prophylaxis of HIV Infection
Intervention  ICMJE
  • Drug: Oral Lenacapavir (LEN)
    Tablets administered orally without regard to food
    Other Name: GS-6207
  • Drug: F/TDF
    Tablets administered orally
    Other Name: Truvada®
  • Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
    Administered via SC injections
    Other Name: GS-6207
  • Drug: Placebo SC LEN
    Administered via SC injections
  • Drug: PTM F/TDF
    Tablets administered orally
  • Drug: PTM Oral LEN
    Tablets administered orally
  • Drug: F/TAF (for US participants only)
    F/TAF tablets administered orally once daily
Study Arms  ICMJE
  • Experimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF

    Participants will receive the following for at least 52 weeks:

    • Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks
    • Oral PTM Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) once daily
    • Oral LEN 600 mg on Days 1 and 2

    Participants will receive oral LEN if SC injections are not available

    Interventions:
    • Drug: Oral Lenacapavir (LEN)
    • Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
    • Drug: PTM F/TDF
  • Experimental: Blinded Phase: Placebo LEN + F/TDF

    Participants will receive the following for at least 52 weeks:

    • SC LEN placebo every 26 weeks
    • Oral F/TDF 200/300 mg once daily
    • PTM Oral LEN on Days 1 and 2

    Participants will receive oral LEN placebo if SC injections are not available

    Interventions:
    • Drug: F/TDF
    • Drug: Placebo SC LEN
    • Drug: PTM Oral LEN
  • Experimental: LEN Open-Label Extension (OLE) Phase

    After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase.

    Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses.

    Participants randomized to F/TDF will receive SC LEN 927 mg on OLE Day 1, OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2.

    Interventions:
    • Drug: Oral Lenacapavir (LEN)
    • Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
  • Experimental: PK Tail Phase

    At the completion of the LEN OLE phase, participants will transition into the PK Tail phase.

    Additionally, participants that prematurely discontinue the study drug during blinded phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase are also eligible to transition to the PK Tail Phase.

    Participants will receive oral F/TDF (or Emtricitabine/Tenofovir Alafenamide (F/TAF) for US participants only) once daily for 78 weeks beginning 26 weeks after the last injection of LEN.

    Interventions:
    • Drug: F/TDF
    • Drug: F/TAF (for US participants only)
Publications * Cespedes M, Das M, Hojilla JC, Blumenthal J, Mounzer K, Ramgopal M, Hodge T, Torres TS, Peterson C, Shibase S, Elliott A, Demidont AC, Callaghan L, Watson CC, Carter C, Kintu A, Baeten JM, Ogbuagu O. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PLoS One. 2022 Jun 3;17(6):e0267780. doi: 10.1371/journal.pone.0267780. eCollection 2022.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2021)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2027
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

Incidence Phase

  • CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
  • HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months
  • Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:

    • Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks
    • History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks
    • Self-reported use of stimulants with sex in the last 12 weeks

Randomized Phase

  • Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT)
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr)

Key Exclusion Criteria:

Incidence Phase

  • Prior use of oral PrEP (including F/TDF or F/TAF) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir)
  • Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation

Randomized Phase

  • Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection
  • Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Cisgender male, Transgender male, Transgender female, and Gender non-binary
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Puerto Rico,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04925752
Other Study ID Numbers  ICMJE GS-US-528-9023
DOH-27-102021-6681 ( Other Identifier: South African National Clinical Trial Registry )
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Gilead Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gilead Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP