Study Details

OVERVIEW

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 (PURPOSE 4)

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

true

Medical Condition

Pre-Exposure Prophylaxis of HIV Infection

Gender

N/A

Date

December 2023 - December 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Eligibility Information

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

Locations

Locations (8)

UCSD AntiViral Research Center (AVRC)

San Diego, California, United States, 92103

University of Miami - Converge Miami Building

Miami, Florida, United States, 33136

Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research

Baltimore, Maryland, United States, 21287

Rutgers New Jersey Medical School, Department of Medicine

Newark, New Jersey, United States, 07103

ICAP at Columbia University- Bronx Prevention Center

Bronx, New York, United States, 10451

University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit

Philadelphia, Pennsylvania, United States, 19104

Houston AIDS Research Team CRS

Houston, Texas, United States, 77030

West Virginia University

Morgantown, West Virginia, United States, 26506

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