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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 : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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) infection relative to the background HIV 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 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 Coverage Phase.

The primary objective for the Incidence Phase of this study is to estimate the HIV background incidence rate. The primary objective of the Randomized Phase of this study is to evaluate the efficacy of lenacapavir for HIV 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 infection.


Condition or disease Intervention/treatment Phase
Pre-Exposure Prophylaxis of HIV Infection Drug: Oral Lenacapavir (LEN) Drug: F/TDF Drug: Sub-cutaneous (SC) Lenacapavir (LEN) Drug: Placebo SC LEN Drug: PTM F/TDF Drug: PTM Oral LEN Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Non-binary People ≥ 16 Years of Age Who Have Sex With Partners Assigned Male at Birth and Are at Risk for HIV Infection
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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
Drug: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Other Name: GS-6207

Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Other Name: GS-6207

Drug: PTM F/TDF
Tablets administered orally

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
Drug: F/TDF
Tablets administered orally
Other Name: Truvada®

Drug: Placebo SC LEN
Administered via SC injections

Drug: PTM Oral LEN
Tablets administered orally

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 OLE Week 52 and will also receive oral LEN 600 mg on OLE Days 1 and 2.

Drug: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Other Name: GS-6207

Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Other Name: GS-6207

Experimental: PK Tail Coverage Phase

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

Participants will receive oral F/TDF once daily for 78 weeks beginning 26 weeks after the last injection of LEN.

Drug: F/TDF
Tablets administered orally
Other Name: Truvada®




Primary Outcome Measures :
  1. Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY) [ Time Frame: At Screening ]
  2. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary
Accepts Healthy Volunteers:   Yes
Criteria

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
    • Documented 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 Ab/Ag test confirmed with central HIV-1 testing
  • 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 long-acting systemic PrEP (including cabotegravir or islatravir trials)
  • Prior recipient of an HIV vaccine

Randomized Phase

  • Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925752


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

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Additional Information:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04925752    
Other Study ID Numbers: GS-US-528-9023
DOH-27-102021-6681 ( Other Identifier: South African National Clinical Trial Registry )
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
HIV Infections
Acquired Immunodeficiency Syndrome
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents