Phase 2 Study of ISL+ULO QW in Virologically Suppressed Adults With HIV-1

 

GS Wonders 1

Purpose of study:  

To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing BVY in virologically suppressed PWH at Week 24

Major requirements for entering the study (things that must be true for you): 

  • Participants 18 years of age or older and able to understand and give written informed consent.
  • Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception as described in Appendix 11.5.
  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
  • Receiving BVY for ≥ 24 weeks prior to screening.

Events or conditions that would prevent you from participating (things that cannot be true about you):  

  • Prior use of, or exposure to LEN, GS-1720, or GS-4182.
  • History of virologic failure while on an INSTI-based regimen.
  • Documented INSTI resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
  • Prior use of any LA parenteral ARVs such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.

Treatment: 

  • In the randomized, open-label Phase 2, single agent GS-1720 and GS-4182 tablets will be coadministered for at least 48 weeks.

Procedures: 

  • Blood tests at clinic visits
  • Sparse PK
  • Clinical assessments

Duration of Study:  

Participants will be treated for at least 48 weeks during the Randomized Phase. After Week 48, participants will continue to receive study drugs until the ERT. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead elects to discontinue the study, whichever occurs first.

Contact information:  

Clinical Research Coordinator: Audrey Soohoo   

Email: [email protected]  

Phone number: 415-806-8554