Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)

A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Oral Lenacapavir; Drug: Subcutaneous Lenacapavir; Drug: F/TAF; Drug: TAF; Drug: BIC; Drug: B/F/TAF

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic, 10103
    • Instituto Dominicano de Estudios Virologicos (IDEV)
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • HOPE Clinical Research
  • San Juan, Puerto Rico, 00909-1711
    • Clinical Research Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Proyecto ACTU, School of Medicine, University of Puerto Rico
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Valleywise Community Health Center - McDowell
    • Phoenix, Arizona, United States, 85015
      • Pueblo Family Physicians
  • California
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group Inc
    • Los Angeles, California, United States, 90069
      • Mills Clinical Research at Men's Health Foundation
    • Palm Springs, California, United States, 92264
      • Eisenhower Health Center at Rimrock
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Denver, University of Colorado Hospital
    • Denver, Colorado, United States, 80204
      • Denver Public Health
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University; School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
    • Washington, District of Columbia, United States, 20017
      • Washington Health Institute
    • Washington, District of Columbia, United States, 20009
      • Whitman-Walker Institute, Inc.
  • Florida
    • DeLand, Florida, United States, 32720
      • Midland Florida Clinical Research Center, LLC
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center
    • Hialeah, Florida, United States, 33016
      • Floridian Clinical Research
    • Miami, Florida, United States, 33133
      • AHF-The Kinder Medical Group
    • Miami Beach, Florida, United States, 33140
      • AIDS Healthcare Foundation - South Beach
    • Orlando, Florida, United States, 32803-1851
      • Orlando Immunology Center
    • Tampa, Florida, United States, 33614
      • St. Joseph's Hospital Comprehensive Research Institute
    • West Palm Beach, Florida, United States, 33401
      • Triple O Research Institute, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Atlanta ID Group, PC
    • Augusta, Georgia, United States, 30912
      • August University Medical Center
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialists of Atlanta
    • Macon, Georgia, United States, 31201
      • Mercer University, Department of Internal Medicine
    • Savannah, Georgia, United States, 31401
      • Chatham County Health Department
  • Illinois
    • Chicago, Illinois, United States, 60613
      • Howard Brown Health Center
    • Chicago, Illinois, United States, 60657
      • Northstar Healthcare
  • Indiana
    • Indianapolis, Indiana, United States, 46077
      • Indiana University Infectious Diseases Research
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center
    • Southfield, Michigan, United States, 48075
      • St. John Newland Medical Associates
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • KC Care Health Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10001
      • AHF-Midtown
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • East Carolina University, The Brody School of Medicine
    • Huntersville, North Carolina, United States, 28078
      • Rosedale Infectious Diseases
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44106
      • Case Clinical Research Site/University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Bellaire, Texas, United States, 77401
      • St Hope Foundation
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants, P.A.
    • Dallas, Texas, United States, 75208
      • Prism Health North Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Centers for Infectious Disease Associates
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, INC.
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
  • Washington
    • Seattle, Washington, United States, 98104
      • Peter Shalit, M.D.
    • Spokane, Washington, United States, 99204
      • MultiCare Rockwood HIV Critical Care Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to screening is permitted
• HIV-1 ribonucleic acid (RNA) ≥ 200 copies/mL at screening
• Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening

Key Exclusion Criteria:

• Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenacapavir, F/TAF, and TAF; Induction phase: Participants will receive lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Drug: Oral Lenacapavir; Tablets administered without regard to food; Other Names: GS-6207; Drug: Subcutaneous Lenacapavir; Administered in the abdomen via subcutaneous injections; Other Names: GS-6207; Drug: F/TAF; Tablets administered without regard to food; Other Names: Descovy®; Drug: TAF; Tablets administered without regard to food
Experimental: Lenacapavir, F/TAF, and BIC; Induction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Drug: Oral Lenacapavir; Tablets administered without regard to food; Other Names: GS-6207; Drug: Subcutaneous Lenacapavir; Administered in the abdomen via subcutaneous injections; Other Names: GS-6207; Drug: F/TAF; Tablets administered without regard to food; Other Names: Descovy®; Drug: BIC; Tablets administered without regard to food
Experimental: Lenacapavir and F/TAF; Induction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Drug: Oral Lenacapavir; Tablets administered without regard to food; Other Names: GS-6207; Drug: F/TAF; Tablets administered without regard to food; Other Names: Descovy®
Active Comparator: B/F/TAF; Participants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study up to Week 80	Drug: B/F/TAF; Tablets administered without regard to food; Other Names: Biktarvy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 54 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 54 window was between Day 323 and 413 (inclusive). Percentages were rounded off.	Week 54

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK of TAF and TFV (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 1	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
PK of TAF and TFV: Time (Observed Time Point) of Cmax (Tmax) on Day 1	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
PK of TFV: Last Observed Quantifiable Concentration of the Drug (Clast) on Day 1	Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK sub study analysis was conducted for Group 1 and 2 on Day 1.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
PK of TAF and TFV: AUClast at Weeks 16, 22, or 28	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF and TFV: Cmax at Weeks 16, 22, or 28	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF and TFV: Tmax at Weeks 16, 22, or 28	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TFV: Clast at Weeks 16, 22, or 28	Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TFV was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF: AUClast at Week 38	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF: Cmax at Week 38	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF: Tmax at Week 38	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of Tenofovir Diphosphate (TFV-DP): AUClast at Weeks 4, 10, 16, or 22	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A peripheral blood mononuclear cell (PBMC) substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 1, 2, and 6 hours postdose
PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 22	Cmax is defined as the maximum observed concentration of drug. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 1, 2, and 6 hours postdose
PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 22	Tmax is defined as the time (observed time point) of Cmax. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.	0 hours (Predose) and at 1, 2, and 6 hours postdose
PK of Bictegravir (BIC): AUClast at Week 38	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of BIC: Cmax at Week 38	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of BIC: Tmax at Week 38	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of BIC: Clast at Week 38	Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 28 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 28 window was between Days 176 and 231 (inclusive). Percentages were rounded off.	Week 28
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 38 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 38 window was between Days 232 and 322 (inclusive). Percentages were rounded off.	Week 38
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 80 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The Week 80 window was between Days 505 and 595 (inclusive). Percentages were rounded off.	Week 80
Change From Baseline in Log10 HIV-1 RNA at Week 28		Baseline, Week 28
Change From Baseline in Log10 HIV-1 RNA at Week 38		Baseline, Week 38
Change From Baseline in Log10 HIV-1 RNA at Week 54		Baseline, Week 54
Change From Baseline in Log10 HIV-1 RNA at Week 80		Baseline, Week 80
Change From Baseline in Clusters of Differentiation 4+ (CD4+) Cell Count at Week 28		Baseline, Week 28
Change From Baseline in CD4+ Cell Count at Week 38		Baseline, Week 38
Change From Baseline in CD4+ Cell Count at Week 54		Baseline, Week 54
Change From Baseline in CD4+ Cell Count at Week 80		Baseline, Week 80
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. Percentages were rounded off.	Up to 174.9 weeks
Percentage of Participants Who Experienced Maximum Postbaseline Laboratory Abnormalities	Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline visit, up to last exposure date for participants who permanently discontinued study drug. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening. Percentages were rounded off.	Up to 174.9 weeks
Pharmacokinetics (PK) of LEN: Plasma LEN Pre-dose Concentrations for SC LEN		Day 2, 8, Day 1 SC (Day 15), Week 28 and Week 54
PK of LEN : Plasma LEN Single Anytime Concentrations for the Oral LEN + DVY		Day 2, 8, 15 , Week 28 and Week 54
PK of TAF (Tenofovir Alafenamide) and TFV (Tenofovir): Area Under the Concentration Versus Time Curve (AUClast) on Day 1	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2) and at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Harris P, Henderson R, Hayward P. Highlights from the 11th IAS Conference on Science. Lancet HIV. 2021 Aug;8(8):e459. doi: 10.1016/S2352-3018(21)00161-2. No abstract available.
• Gupta SK, Berhe M, Crofoot G, Benson P, Ramgopal M, Sims J, McDonald C, Ruane P, Sanchez WE, Scribner A, Liu SY, VanderVeen LA, Dvory-Sobol H, Rhee MS, Baeten JM, Koenig E. Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial. Lancet HIV. 2023 Jan;10(1):e15-e23. doi: 10.1016/S2352-3018(22)00291-0.
• VanderVeen, L. A., et al. Resistance Analysis of Long-Acting Lenacapavir in People With HIV Who are Treatment-Naïve After 80 Weeks of Treatment [Poster14]. European Meeting on HIV & Hepatitis 2023, Rome, Italy.
• Jogiraju V, Shelton M, Dheri P, Ling J, Wang H, Dvory-Sobol H, et al. Pharmacokinetics of Lenacapavir Alone and When Coadministered With Other Antiretrovirals in People With HIV [Poster PII-056]. American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; 2023 22-24 March; Atlanta, GA.
• Hagins D, Koenig E, Safran R, Santiago L, Wohlfeiler M, Hsiao C, et al. Long-Acting Lenacapavir in a Combination Regimen for Treatment Naïve PWH: Week 80 [Poster 522]. Conference on Retroviruses and Opportunistic Infections (CROI); 2023 19-22 February; Seattle, WA.
• VanderVeen LA, Margot N, Naik V, Dvory-Sobol H, Rhee MS, Callebaut C. Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People With HIV at 54 Weeks [Poster EPB239]. AIDS 2022; 2022 29 July-2 August; Montreal, Quebec, Canada.
• Gupta SK, Sims J, Brinson C, Cruickshank FA, Oguchi G, Morales J, et al. Lenacapavir as part of a Combination Regimen in Treatment-Naïve People with HIV: Week 54 Results [Presentation]. Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 2022 12-16 February.
• VanderVeen, L, Margot N, Naik V, et al. Interim Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People with HIV at 28 Weeks (CALIBRATE) [Abstract Oral 73]. Presented at: ID Week; 2021 September 29 - October 03.
• Gupta SK, Berhe M, Crofoot G, et al. Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as part of a Combination Regimen in Treatment-Naïve People with HIV: Interim 16-week Results of a Randomized, Open-label, Phase 2 Induction-Maintenance Study (CALIBRATE) [Abstract OALB0302]. Presented at: International AIDS Society (IAS) Conference; 2021 July 18-21.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Actual): October 5, 2021
• Study Completion (Actual): September 19, 2023

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine tenofovir alafenamide
• Other Study ID Numbers: GS-US-200-4334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No