Clinical trial NCT06513312: Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
Official title: A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pre-Exposure Prophylaxis of HIV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 262
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 learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).

The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.


Eligibility criteria: Key Inclusion Criteria:

* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
* Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people.
* Increased likelihood of HIV acquisition as indicated by at least one of the following:

  1. Condomless sex with ≥ 2 partners in the past 6 months
  2. Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months
  3. Engagement in sex work or transactional sex in the past 12 months
  4. Use of ≥ 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in the past 12 months
  5. Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months
* 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) at screening.

  1) If rapid HIV-1/2 Ab/Ag tests are unavailable due to extenuating circumstances, sites may run a laboratory-instrumented HIV-1/2 Ab/Ag test at their local laboratory, only if they confirm this is a fourth-generation assay and the time from blood draw to injection at any injection visit is \< 48 hours.
* Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr):

  * (140 - age in years) × (weight in kg) x (0.85 if female) = CLcr (mL/min) / 72 × (serum creatinine in mg/dL)

Key Exclusion Criteria:

* Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
* Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation. For cabotegravir, this is defined as 4 weeks since the next injection was due (ie, 12 weeks since their most recent cabotegravir injection).
* Current use of nPEP, unless the prescribed course will be completed prior to randomization.
* Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
* Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
* Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding).
* Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks
timeFrame: Up to Week 52
Secondary outcomes:
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
timeFrame: First dose date up to 30 days post last dose at Week 78
measure: Overall acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with responses to Question on Acceptability
timeFrame: Up to Week 52
measure: Pharmacokinetic (PK) Parameter: Ctrough for LEN at Week 26
timeFrame: Week 26
measure: PK Parameter: Ctrough for LEN at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital Avicenne
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Nice
country: France
facility: CHU Nice Archet
city: Paris
country: France
facility: Hopital Saint Louis - Assistance Publique des Hopitaux de Paris
city: Paris
country: France
facility: APHP Hopital Saint-Antoine
city: Paris
country: France
facility: APHP Bichat Claude-Bernard Hospital
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital
city: Brighton
country: United Kingdom
facility: Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Axess Sexual Health, Liverpool University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS Trust
city: London
country: United Kingdom
facility: Homerton Healthcare NHS Foundation Trust, Homerton University Hospital
city: London
country: United Kingdom
facility: Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust, Clinical Research Facility, Chelsea and Westminster Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: