A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1

Summary

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  ISL

  ISL 2 x 1 mg oral capsules administered qw for 96 weeks

• Drug
  ULO

  ULO 2 x 100 mg oral tablets administered qw for 96 weeks

• Drug
  BIC/FTC/TAF

  BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

• Drug
  Placebo for BIC/FTC/TAF

  BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks

• Drug
  Placebo to ISL/ULO

  ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

• Drug
  ISL/ULO

  ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

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