ACTIVE_NOT_RECRUITING

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

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Conditions

Pre-Exposure Prophylaxis of HIV Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2023-12-13
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06101342

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Evidence of recent injection (eg, track marks).
  3. * Self-report of injection paraphernalia sharing in the prior 30 days.
  4. * Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
  5. * 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).
  6. * Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).
  1. * Self-reported history of previous positive results on an HIV test.
  2. * Any reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
  3. * 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.
  4. * 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).
  5. * Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).
  6. * Acute viral hepatitis A or acute or chronic hepatitis B or C infection.
  7. * Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
  8. * 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).

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

UCLA Vine Street Clinic
Los Angeles, California, 90038
United States
UCSD AntiViral Research Center (AVRC)
San Diego, California, 92103
United States
University of Miami - Converge Miami Building
Miami, Florida, 33136
United States
Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research
Baltimore, Maryland, 21287
United States
Rutgers New Jersey Medical School, Department of Medicine
Newark, New Jersey, 07103
United States
ICAP at Columbia University- Bronx Prevention Center
Bronx, New York, 10451
United States
University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit
Philadelphia, Pennsylvania, 19104
United States
Houston AIDS Research Team CRS
Houston, Texas, 77030
United States
West Virginia University
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Pre-Exposure Prophylaxis of HIV Infection