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Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

About

Brief Summary

The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
16 Years
Maximum Age
N/A

Key Inclusion Criteria:

Incidence Phase

  • CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
  • HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months.
  • Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:
    • Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks.
    • History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks.
    • Self-reported use of stimulants with sex in the last 12 weeks. Randomized Phase
  • Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

Key Exclusion Criteria:

Incidence Phase

  • Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir).
  • Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation. Randomized Phase
  • 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.

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

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Study Stats
Protocol No.
21-001200
Category
Infectious Diseases
Contact
Sandra Macnicoll
Location
  • UCLA Hollywood
For Providers
NCT No.
NCT04925752
For detailed technical eligibility, visit ClinicalTrials.gov.