HIV-1-infectionPhase 2CALIBRATENCT04143594
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV
A Phase 2 study testing Oral Lenacapavir, F/TAF and Subcutaneous Lenacapavir in people with HIV-1-infection, run by Gilead Sciences at 53 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Oral Lenacapavir, F/TAF and Subcutaneous Lenacapavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 53 sitesin 3 countries
- Study dates
- 22 Nov 2019to 19 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
53 sites in 3 countries.
53 sites in 3 countries
United States49 sites
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003
Atlanta ID Group, PC
Atlanta, Georgia, 30309
August University Medical Center
Augusta, Georgia, 30912
University of Colorado, Denver, University of Colorado Hospital
Aurora, Colorado, 80045
Central Texas Clinical Research
Austin, Texas, 78705
St Hope Foundation
Bellaire, Texas, 77401
Be Well Medical Center
Berkley, Michigan, 48072
Howard Brown Health Center
Chicago, Illinois, 60613
Northstar Healthcare
Chicago, Illinois, 60657
University of Cincinnati
Cincinnati, Ohio, 45267
Case Clinical Research Site/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Medical Center
Columbus, Ohio, 43210
Prism Health North Texas
Dallas, Texas, 75208
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
Denver Public Health
Denver, Colorado, 80204
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76104
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
East Carolina University, The Brody School of Medicine
Greenville, North Carolina, 27858
Floridian Clinical Research
Hialeah, Florida, 33016
The Crofoot Research Center, Inc.
Houston, Texas, 77098
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078
Indiana University Infectious Diseases Research
Indianapolis, Indiana, 46077
KC CARE Health Center
Kansas City, Missouri, 64111
DCOL Center for Clinical Research
Longview, Texas, 75605
Ruane Clinical Research Group Inc
Los Angeles, California, 90036
Mills Clinical Research at Men's Health Foundation
Los Angeles, California, 90069
Mercer University, Department of Internal Medicine
Macon, Georgia, 31201
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
AHF-The Kinder Medical Group
Miami, Florida, 33133
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, 33140
Yale University; School of Medicine
New Haven, Connecticut, 06510
AHF-Midtown
New York, New York, 10001
Orlando Immunology Center
Orlando, Florida, 32803-1851
Eisenhower Health Center at Rimrock
Palm Springs, California, 92264
Valleywise Community Health Center - McDowell
Phoenix, Arizona, 85004
Pueblo Family Physicians
Phoenix, Arizona, 85015
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Chatham County Health Department
Savannah, Georgia, 31401
Peter Shalit, M.D.
Seattle, Washington, 98104
St. John Newland Medical Associates
Southfield, Michigan, 48075
MultiCare Rockwood HIV Critical Care Clinic
Spokane, Washington, 99204
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, 33614
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Whitman-Walker Institute, Inc.
Washington D.C., District of Columbia, 20009
Washington Health Institute
Washington D.C., District of Columbia, 20017
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401
Puerto Rico3 sites
Clinical Research Puerto Rico
San Juan, 00909-1711
HOPE Clinical Research
San Juan, 00909
Proyecto ACTU, School of Medicine, University of Puerto Rico
San Juan, 00935
Dominican Republic1 site
Instituto Dominicano de Estudios Virológicos (IDEV)
Santo Domingo, 10103
About this study
Official title: 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).
- Conditions
- HIV-1-infection
- Being tested
- Oral Lenacapavir, F/TAF, Subcutaneous Lenacapavir, TAF, BIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral LenacapavirDrug
Also called GS-6207
Tablets administered without regard to food
F/TAFDrug
Also called Descovy®
Tablets administered without regard to food
Subcutaneous LenacapavirDrug
Also called GS-6207
Administered in the abdomen via subcutaneous injections
TAFDrug
Tablets administered without regard to food
BICDrug
Tablets administered without regard to food
B/F/TAFDrug
Also called Biktarvy®
Tablets administered without regard to food
| Study group | Role | What they receive |
|---|---|---|
| Lenacapavir, F/TAF, and TAF | Experimental | 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. Receives: Drug: Oral Lenacapavir; Drug: F/TAF; Drug: Subcutaneous Lenacapavir; Drug: TAF |
| Lenacapavir, F/TAF, and BIC | Experimental | 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. Receives: Drug: Oral Lenacapavir; Drug: F/TAF; Drug: Subcutaneous Lenacapavir; Drug: BIC |
| Lenacapavir and F/TAF | Experimental | 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. Receives: Drug: Oral Lenacapavir; Drug: F/TAF |
| B/F/TAF | Active comparator | 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 Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 54
Secondary outcomes (33)
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.
Measured: 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.
Measured: 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.
Measured: Week 80
Change From Baseline in Log10 HIV-1 RNA at Week 28
Measured: Baseline, Week 28
Change From Baseline in Log10 HIV-1 RNA at Week 38
Measured: Baseline, Week 38
Change From Baseline in Log10 HIV-1 RNA at Week 54
Measured: Baseline, Week 54
Change From Baseline in Log10 HIV-1 RNA at Week 80
Measured: Baseline, Week 80
Change From Baseline in Clusters of Differentiation 4+ (CD4+) Cell Count at Week 28
Measured: Baseline, Week 28
Change From Baseline in CD4+ Cell Count at Week 38
Measured: Baseline, Week 38
Change From Baseline in CD4+ Cell Count at Week 54
Measured: Baseline, Week 54
Change From Baseline in CD4+ Cell Count at Week 80
Measured: 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.
Measured: 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.
Measured: Up to 174.9 weeks
Pharmacokinetics (PK) of LEN: Plasma LEN Pre-dose Concentrations for SC LEN
Measured: 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
Measured: 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.
Measured: 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 (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start22 Nov 2019
- Primary completion5 Oct 2021
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143594
- Sponsor's protocol ID
- GS-US-200-4334
- Acronym
- CALIBRATE
- Status last verified
- Sep 2024
- First submitted
- 28 Oct 2019
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 36566079VanderVeen, 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.
Hagins D, Berhe M, Crofoot GE, Ramgopal MN, Sims J, McDonald C, Ruane PJ, Sanchez WE, Scribner A, Benson P, Liu SY, Vanderveen LA, Dvory-Sobol H, Rhee MS, Gupta SK. Final efficacy and safety of twice-yearly subcutaneous lenacapavir in treatment-naive people with HIV. AIDS. 2026 Mar 1;40(3):302-311. doi: 10.1097/QAD.0000000000004372. Epub 2025 Oct 6.
PubMed 41056006Harris 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.
PubMed 34358495
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04143594
- Acronym / sponsor ID
- CALIBRATE / GS-US-200-4334
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 19 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lenacapavir, F/TAF, and TAF | Experimental | Drug: Oral Lenacapavir, Drug: F/TAF, Drug: Subcutaneous Lenacapavir, Drug: TAFInduction 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. |
| Lenacapavir, F/TAF, and BIC | Experimental | Drug: Oral Lenacapavir, Drug: F/TAF, Drug: Subcutaneous Lenacapavir, Drug: BICInduction 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. |
| Lenacapavir and F/TAF | Experimental | Drug: Oral Lenacapavir, Drug: F/TAFInduction 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. |
| B/F/TAF | Active comparator | Drug: B/F/TAFParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (2 listed)
- Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral LenacapavirAlso: GS-6207Tablets administered without regard to food | Drug | Lenacapavir and F/TAF, Lenacapavir, F/TAF, and BIC, Lenacapavir, F/TAF, and TAF |
| F/TAFAlso: Descovy®Tablets administered without regard to food | Drug | Lenacapavir and F/TAF, Lenacapavir, F/TAF, and BIC, Lenacapavir, F/TAF, and TAF |
| Subcutaneous LenacapavirAlso: GS-6207Administered in the abdomen via subcutaneous injections | Drug | Lenacapavir, F/TAF, and BIC, Lenacapavir, F/TAF, and TAF |
| TAFTablets administered without regard to food | Drug | Lenacapavir, F/TAF, and TAF |
| BICTablets administered without regard to food | Drug | Lenacapavir, F/TAF, and BIC |
| B/F/TAFAlso: Biktarvy®Tablets administered without regard to food | Drug | B/F/TAF |
Primary outcome
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
Time frame: Week 54
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.
33 secondary outcomes
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 28
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 38
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 80
Change From Baseline in Log10 HIV-1 RNA at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Log10 HIV-1 RNA at Week 38
Time frame: Baseline, Week 38
Change From Baseline in Log10 HIV-1 RNA at Week 54
Time frame: Baseline, Week 54
Change From Baseline in Log10 HIV-1 RNA at Week 80
Time frame: Baseline, Week 80
Change From Baseline in Clusters of Differentiation 4+ (CD4+) Cell Count at Week 28
Time frame: Baseline, Week 28
Change From Baseline in CD4+ Cell Count at Week 38
Time frame: Baseline, Week 38
Change From Baseline in CD4+ Cell Count at Week 54
Time frame: Baseline, Week 54
Change From Baseline in CD4+ Cell Count at Week 80
Time frame: Baseline, Week 80
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 174.9 weeks
Percentage of Participants Who Experienced Maximum Postbaseline Laboratory Abnormalities
Time frame: Up to 174.9 weeks
Pharmacokinetics (PK) of LEN: Plasma LEN Pre-dose Concentrations for SC LEN
Time frame: 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
Time frame: 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
Time frame: 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 (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF: AUClast at Week 38
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF: Cmax at Week 38
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of TAF: Tmax at Week 38
Time frame: 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
Time frame: 0 hours (Predose) and at 1, 2, and 6 hours postdose
PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 22
Time frame: 0 hours (Predose) and at 1, 2, and 6 hours postdose
PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 22
Time frame: 0 hours (Predose) and at 1, 2, and 6 hours postdose
PK of Bictegravir (BIC): AUClast at Week 38
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of BIC: Cmax at Week 38
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of BIC: Tmax at Week 38
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
PK of BIC: Clast at Week 38
Time frame: 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36566079Gupta 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.
- BackgroundVanderVeen, 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.
- BackgroundJogiraju 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.
- BackgroundHagins 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.
- BackgroundVanderVeen 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.
- BackgroundGupta 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.
- BackgroundVanderVeen, 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.
- BackgroundGupta 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.
- Derived from this study: PubMed 41056006Hagins D, Berhe M, Crofoot GE, Ramgopal MN, Sims J, McDonald C, Ruane PJ, Sanchez WE, Scribner A, Benson P, Liu SY, Vanderveen LA, Dvory-Sobol H, Rhee MS, Gupta SK. Final efficacy and safety of twice-yearly subcutaneous lenacapavir in treatment-naive people with HIV. AIDS. 2026 Mar 1;40(3):302-311. doi: 10.1097/QAD.0000000000004372. Epub 2025 Oct 6.
- Derived from this study: PubMed 34358495Harris 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.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
53 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Lenacapavir, F/TAF and Subcutaneous Lenacapavir in people with HIV-1-infection, run by Gilead Sciences at 53 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Puerto Rico, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 54). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143594, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.