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

NCT04925752

Active Not RecruitingPhase 3

Sponsor: Gilead Sciences

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Interventions: Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF

Countries: United States, Argentina, Brazil, Mexico, Peru, Puerto Rico, South Africa, Thailand

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 PrEP in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (93)
  • Birmingham, Alabama, United States
  • Loma Linda, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Palm Springs, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Washington D.C., District of Columbia, United States
  • Fort Lauderdale, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Ft. Pierce, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami Gardens, Florida, United States
  • Orlando, Florida, United States
  • Sarasota, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • + 63 more on CT.gov