CALIBRATE

Status:
Phase:Open Label, II
Principal Investigator(s):
Objective:The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with HIV (PLWH).   Last updated May 17, 2022
Prevention Option(s):Combination Prevention
Study Design:Controlled, Open label, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Lenacapavir, F/TAF, and TAF Induction: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily emtricitabine/tenofovir alafenamide (F/TAF) 200/25mg from Day 1 onwards for a total of 28 weeks. On Day 15 participants will receive subcutaneous (SC) lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin taking oral daily TAF 25 mg. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily TAF 25 mg from Week 80 onwards. Drug: Oral Lenacapavir Tablets administered without regard to food Other Name: GS-6207 Drug: F/TAF Tablets administered without regard to food Other Name: Descovy® Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections Other Name: GS-6207 Drug: TAF Tablets administered without regard to food
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: Lenacapavir, F/TAF, and BIC Induction: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily F/TAF 200/25 mg from Day 1 onward for a total of 28 weeks. On Day 15 participants will receive SC lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin oral daily bictegravir (BIC) 75 mg. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily bictegravir (BIC) 75 mg from Week 80 onwards. Drug: Oral Lenacapavir Tablets administered without regard to food Other Name: GS-6207 Drug: F/TAF Tablets administered without regard to food Other Name: Descovy® Drug: Subcutaneous Lenacapavir Administered in the abdomen via subcutaneous injections Other Name: GS-6207 Drug: BIC Tablets administered without regard to food
Mode of DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: Lenacapavir and F/TAF Participants will receive oral lenacapavir 600 mg at Day 1 and Day 2. On Day 3, participants will begin oral daily lenacapavir 50 mg. Participants will begin oral daily F/TAF 200/25 mg from Day 1 onwards. Participants willing to continue the study beyond Week 80 will continue to receive oral daily lenacapavir 50 mg and oral daily F/TAF 200/25 mg from Week 80 onwards. Drug: Oral Lenacapavir Tablets administered without regard to food Other Name: GS-6207 Drug: F/TAF Tablets administered without regard to food Other Name: Descovy®
Mode of DeliveryTablet
ARMsExperimental
DescriptionActive Comparator: B/F/TAF Participants will receive oral daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg at Day 1 and throughout their participation in the study. Drug: B/F/TAF Tablets administered without regard to food Other Name: Biktarvy®
Mode of DeliveryTablet
ARMsActive Comparator
Official Code: NCT04143594
Trial Sponsors: Gilead
Start Date
End Date
November 22, 2019
May 1, 2023
Enrollment:183
Age range: 18 Years ↔ any
Population:Cisgender Men, Cisgender Women