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

Description

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.

Conditions

Pre-Exposure Prophylaxis of HIV Infection

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pre-Exposure Prophylaxis of HIV Infection
Intervention / Treatment

-

Contacts and Locations

San Diego

UCSD AntiViral Research Center (AVRC), San Diego, California, United States, 92103

Baltimore

Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research, Baltimore, Maryland, United States, 21287

Newark

Rutgers New Jersey Medical School, Department of Medicine, Newark, New Jersey, United States, 07103

Bronx

ICAP at Columbia University- Bronx Prevention Center, Bronx, New York, United States, 10451

Philadelphia

University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit, Philadelphia, Pennsylvania, United States, 19104

Houston

Houston AIDS Research Team CRS, Houston, Texas, United States, 77030

Morgantown

West Virginia University, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2028-12