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Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (PURPOSE 4)

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ClinicalTrials.gov Identifier: NCT06101342
Recruitment Status : Recruiting
First Posted : October 26, 2023
Last Update Posted : April 29, 2024
Sponsor:
Collaborators:
HIV Prevention Trials Network
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:

The goals of this clinical study are 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 pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US).

The primary objectives of this study are to characterize the pharmacokinetics (PK) of LEN and to evaluate the safety of LEN and F/TDF for PrEP in US PWID.


Condition or disease Intervention/treatment Phase
Pre-Exposure Prophylaxis of HIV Infection Drug: Lenacapavir Injection Drug: Lenacapavir Tablet Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) Phase 2

Study Design
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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 and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs
Actual Study Start Date : December 13, 2023
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Randomized Phase: Lenacapavir (LEN) Group
Participants will receive subcutaneous (SC) LEN 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.
 Drug: Lenacapavir Injection
Administered subcutaneously
Other Name: GS-6207

Drug: Lenacapavir Tablet
Administered orally
Other Name: GS-6207
Experimental: Randomized Phase: Emtricitabine/ Tenofovir Disoproxil Fumarate (F/TDF) Group
Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks.
 Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Administered orally
Other Name: Truvada®
Experimental: Pharmacokinetic (PK) Tail Phase: F/TDF
After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF FDC tablets and participants in F/TDF group will continue to receive F/TDF FDC tablets in the PK Tail Phase. All participants will receive F/TDF FDC tablets, once daily for up to 78 weeks beginning 26 weeks after the last LEN injection.
 Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Administered orally
Other Name: Truvada®


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN): LEN Plasma concentration at the End of the Dosing Interval (Week 26) [ Time Frame: Week 26 ]
  2. PK Parameter: Ctrough for LEN: LEN Plasma concentration at the End of the Dosing Interval (Week 52) [ Time Frame: Week 52 ]
  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 with LEN and F/TDF [ Time Frame: First dose date up to 30 days post last dose at Week 78 ]

Secondary Outcome Measures :
  1. 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, the participants will complete 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.

  2. 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, the participants will complete 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.

  3. 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, the participants will complete 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.

  4. Number of Participants with Adherence to LEN, as Assessed by On-time LEN Injections Received [ Time Frame: Up to Week 26 ]
  5. Number of Participants with Adherence to F/TDF as Assessed by Adherence Levels Based on Intracellular Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS) [ Time Frame: Up to Week 78 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Urine drug screen positive for any drug of misuse including, but not limited to, opioids (eg, fentanyl, heroin), stimulants (eg, cocaine, amphetamines), psychoactive drugs (eg, benzodiazepines), or a combination of these drugs.
  • Evidence of recent injection (eg, track marks).
  • Self-report of injection paraphernalia sharing in the prior 30 days.
  • Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
  • 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.
  • Any reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
  • Coenrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation) without prior approval from the Medical Monitor/Joint Clinical Management Committee while participating in this study.
  • 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.
  • Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
  • Evidence of moderate or severe liver fibrosis or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)

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

Contacts and Locations
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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): NCT06101342


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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United States, California
UCSD AntiViral Research Center (AVRC) Recruiting
San Diego, California, United States, 92103
Sponsors and Collaborators
Gilead Sciences
HIV Prevention Trials Network
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT06101342    
Other Study ID Numbers: GS-US-528-6363
First Posted: October 26, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 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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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