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Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04994509
Recruitment Status : Active, not recruiting
First Posted : August 6, 2021
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blinded Phase: LEN + Placebo-to-match (PTM) F/TAF

Participants will receive the following for at least 52 weeks:

  • Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks
  • Oral PTM Emtricitabine/Tenofovir Alafenamide (F/TAF) 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: Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Other Name: GS-6207

Drug: PTM F/TAF
Tablets administered orally

Experimental: Blinded Phase: LEN + PTM F/TDF

Participants will receive the following for at least 52 weeks:

  • SC 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: Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Other Name: GS-6207

Drug: PTM F/TDF
Tablets administered orally

Experimental: Blinded Phase: Placebo LEN + F/TAF

Participants will receive the following for at least 52 weeks:

  • SC placebo LEN every 26 weeks
  • Oral F/TAF 200/25 mg once daily
  • Oral PTM LEN on Days 1 and 2
Drug: F/TAF
Tablets administered orally
Other Name: Descovy®

Drug: Placebo SC LEN
Administered via SC injections

Drug: PTM Oral LEN
Tablets administered orally

Experimental: Blinded Phase: Placebo LEN + F/TDF

Participants will receive the following for at least 52 weeks:

  • SC placebo LEN every 26 weeks
  • Oral F/TDF 200/300 mg once daily
  • Oral PTM 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/TAF or F/TDF will receive SC LEN 927 mg on OLE Day 1 and OLE Week 26, 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: Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Other Name: GS-6207

Experimental: Pharmacokinetic (PK) Tail Coverage Phase

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

Additionally, participants that either prematurely discontinue the study drug during the blinded phase or choose not to continue in the LEN OLE phase (if randomized to LEN in the blinded phase) or who discontinue the study drug 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 LEN injection.

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: 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 3 years) ]

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 3 years) ]
  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 3 years) ]
  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 3 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender Female
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Incidence Phase

    • HIV-1 status unknown at initial screening and no prior human immunodeficiency virus (HIV)-1 testing within the last 3 months.
    • Sexually active (has had > 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM).
  • Randomized Phase

    • Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing.
    • Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening.
    • Body weight ≥ 35 kg.

Key Exclusion Criteria:

  • Prior receipt of an HIV vaccine.
  • Prior use of long-acting systemic HIV pre-exposure prophylaxis (PrEP) or or HIV PEP (postexposure prophylaxis).

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): NCT04994509


Locations
Show Show 28 study locations
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: NCT04994509    
Other Study ID Numbers: GS-US-412-5624
DOH-27- 072021-6125 ( Registry Identifier: South African National Clinical Trial Registry )
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
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
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Attributes
Pathologic Processes
Blood-Borne 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
Slow Virus Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine tenofovir alafenamide
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