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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre-Exposure Prophylaxis of HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lenacapavir Injection

Intervention Type DRUG

Administered subcutaneously

Lenacapavir Tablet

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Intervention Type DRUG

Administered orally

Open-label Extension Phase: LEN

Participants randomized to LEN in the Randomized Phase who choose to participate in the LEN Open-Label Extension (OLE) Phase will receive SC LEN every 26 weeks (± 7 days) and have study visits every 13 weeks (± 7 days). Participants randomized to F/TDF in the Randomized Phase who choose to participate in LEN OLE Phase will switch to SC LEN and have study visits at LEN OLE Day 1, Week 4 (± 2 days), Week 13 (± 7 days), and every 13 weeks (± 7 days) thereafter. SC LEN will be administered at the LEN OLE Day 1 visit and every 26 weeks thereafter. These participants will also receive loading doses of oral LEN on OLE Days 1 and 2. Upon completion of the LEN OLE Phase, participants will transition to local HIV prevention services and return for a 30-day follow-up visit. At that time, participation in the study will end.

Group Type EXPERIMENTAL

Lenacapavir Injection

Intervention Type DRUG

Administered subcutaneously

Lenacapavir Tablet

Intervention Type DRUG

Administered orally

Pharmacokinetic (PK) Tail Phase: F/TDF

Participants eligible for the PK Tail Phase will receive open-label oral F/TDF once daily for up to 78 weeks and complete study visits every 13 weeks (± 7 days). PK Tail Day 1 visit will occur 26 weeks (± 7 days) after the last SC LEN injection.

Group Type EXPERIMENTAL

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Intervention Type DRUG

Administered orally

Interventions

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Lenacapavir Injection

Administered subcutaneously

Intervention Type DRUG

Lenacapavir Tablet

Administered orally

Intervention Type DRUG

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Administered orally

Intervention Type DRUG

Other Intervention Names

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GS-6207 Yeztugo® GS-6207 Truvada®

Eligibility Criteria

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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).

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes