Clinical trial NCT06101342: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pre-Exposure Prophylaxis of HIV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: HIV Prevention Trials Network
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-10-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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). 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.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN): LEN Plasma concentration at the End of the Dosing Interval (Week 26)
timeFrame: Week 26
measure: PK Parameter: Ctrough for LEN: LEN Plasma concentration at the End of the Dosing Interval (Week 52)
timeFrame: Week 52
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 30 days post last dose at Week 78
measure: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities with LEN and F/TDF
timeFrame: First dose date up to 30 days post last dose at Week 78
Secondary outcomes:
measure: General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
timeFrame: Up to Week 52
measure: Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses
timeFrame: Up to Week 52
measure: Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses
timeFrame: Up to Week 52
measure: Number of Participants with Adherence to LEN, as Assessed by On-time LEN Injections Received
timeFrame: Up to Week 26
measure: Number of Participants with Adherence to F/TDF as Assessed by Adherence Levels Based on Intracellular Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)
timeFrame: Up to Week 78
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Vine Street Clinic
state: California
city: San Diego
country: United States
facility: UCSD AntiViral Research Center (AVRC)
state: California
city: Miami
country: United States
facility: University of Miami - Converge Miami Building
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research
state: Maryland
city: Newark
country: United States
facility: Rutgers New Jersey Medical School, Department of Medicine
state: New Jersey
city: Bronx
country: United States
facility: ICAP at Columbia University- Bronx Prevention Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit
state: Pennsylvania
city: Houston
country: United States
facility: Houston AIDS Research Team CRS
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: