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)

March 27, 2024 updated by: Gilead Sciences

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

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:

  • To characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women.
  • To evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women.
  • To evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • UCSD Antiviral Research Center (AVRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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):

    • 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)
    • 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
    • History of STIs, such as gonorrhea, chlamydia, or syphilis
    • Exchange of sex for commodities, such as drugs, money, or shelter
    • Incarceration (jail or prison > 24 hours within the past 5 years)
    • Two or more sexual partners who were assigned male at birth
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • GS-6207
Drug: Lenacapavir Injection
Injection administered subcutaneously
Other Names:
  • 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 Names:
  • 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 Names:
  • Truvada®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to 30 days post last dose at Week 78
First dose date up to 30 days post last dose at Week 78
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.
Week 26
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.
Week 52
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Time Frame: First dose date up to 30 days post last dose at Week 78
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.
Up to Week 52
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.
Up to Week 52
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.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received
Time Frame: Up to Week 26
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
Up to Week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

HIV Prevention Trials Network

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-528-6020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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