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

Gilead Sciences

Status and phase: Enrolling; Phase 2

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Treatments: Drug: Lenacapavir Tablet; Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF); Drug: Lenacapavir Injection

Study type: Interventional

Funder types: NETWORK; Industry; NIH

Identifiers

NCT06101342

GS-US-528-6363

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Randomized Phase: Lenacapavir (LEN) Group

Experimental group

Description:

Participants will receive subcutaneous (SC) LEN 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.

Treatment:

Drug: Lenacapavir Injection

Drug: Lenacapavir Tablet

Randomized Phase: Emtricitabine/ Tenofovir Disoproxil Fumarate (F/TDF) Group

Experimental group

Description:

Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks.

Treatment:

Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Pharmacokinetic (PK) Tail Phase: F/TDF

Experimental group

Description:

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.

Treatment:

Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)