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

• ClinicalTrials.gov Identifier: NCT06101342
• Recruitment Status: Recruiting
• First Posted: October 26, 2023
• Last Update Posted: April 29, 2024
• Sponsor: Gilead Sciences
• 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

Tracking Information

• First Submitted Date: October 20, 2023
• First Posted Date: October 26, 2023
• Last Update Posted Date: April 29, 2024
• Actual Study Start Date: December 13, 2023
• Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2023)

• Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN): LEN Plasma concentration at the End of the Dosing Interval (Week 26) [ Time Frame: Week 26 ]
• PK Parameter: Ctrough for LEN: LEN Plasma concentration at the End of the Dosing Interval (Week 52) [ Time Frame: Week 52 ]
• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 30 days post last dose at Week 78 ]
• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 20, 2023)

• 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.
• 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.
• 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.
• Number of Participants with Adherence to LEN, as Assessed by On-time LEN Injections Received [ Time Frame: Up to Week 26 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Pre-Exposure Prophylaxis of HIV Infection

Intervention

• Drug: Lenacapavir Injection
  Administered subcutaneously
  Other Name: GS-6207
• Drug: Lenacapavir Tablet
  Administered orally
  Other Name: GS-6207
• Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
  Administered orally
  Other Name: Truvada®

Study Arms

• 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.
  Interventions:

  • Drug: Lenacapavir Injection
  • Drug: Lenacapavir Tablet
• 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.
  Intervention: Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
• 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.
  Intervention: Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 20, 2023): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2027
• Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06101342
• Other Study ID Numbers: GS-US-528-6363
• Has Data Monitoring Committee: No

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

• Plan to Share IPD: No

• Current Responsible Party: Gilead Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Gilead Sciences
• Original Study Sponsor: Same as current

Collaborators

• HIV Prevention Trials Network
• National Institute on Drug Abuse (NIDA)
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

• PRS Account: Gilead Sciences
• Verification Date: April 2024