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NCT Number: NCT06101342

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pre-Exposure Prophylaxis of HIV Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA Vine Street Clinic, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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). In individuals with active hepatitis C, Fibrosis-4 (FIB-4) score > 3.25 (formula provided below).

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

Treatment and study plan

Lenacapavir Injection

Drug

Administered subcutaneously

Other names: GS-6207, Yeztugo®

Lenacapavir Tablet

Drug

Administered orally

Other names: GS-6207

Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

Drug

Administered orally

Other names: Truvada®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

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

Registry information

Official study 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

Acronym: PURPOSE 4

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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