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By physician referral or invitation only

A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination with Lenacapavir in Virologically Suppressed People with HIV

This is a Phase 2, randomized, open-label, active-controlled, multicenter study to evaluate the safety, efficacy, and PK (Pharmacokinetics) of ISL (Islatravir) +LEN (Lenacapavir). Virologically suppressed PWH (People living With HIV) who meet all eligibility criteria will be randomized in a 2:1 ratio to 1 of the following 2 groups: Treatment Group 1 (n = 50) Oral weekly ISL administered with LEN (ISL+LEN) Treatment Group 2 (n = 25) Oral daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Contact the Team

Location

Thank you for your interest, but this study is recruiting by invitation only.

North Carolina (Statewide)

Additional Study Information

Principal Investigator

Joseph Eron
Medicine-Infectious Diseases

Study Type

Clinical or Medical
Interventional

Study Topics

HIV/AIDS

IRB Number

21-2334

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