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

NCT04143594 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GS-US-200-4334
• Study Type: interventional
• Target: 183
• Locations: 3 countries
• Sites: 53

Brief 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).

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (33)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm

  Week 28

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm

  Week 38

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm

  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

Study Arms (4)

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.

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.

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.

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

Drug: B/F/TAF

Interventions

Oral Lenacapavir DRUG

Tablets administered without regard to food

Also known as: GS-6207

Lenacapavir and F/TAF; Lenacapavir, F/TAF, and BIC; Lenacapavir, F/TAF, and TAF

F/TAF DRUG

Tablets administered without regard to food

Also known as: Descovy®

Lenacapavir and F/TAF; Lenacapavir, F/TAF, and BIC; Lenacapavir, F/TAF, and TAF

Subcutaneous Lenacapavir DRUG

Administered in the abdomen via subcutaneous injections

Also known as: GS-6207

Lenacapavir, F/TAF, and BIC; Lenacapavir, F/TAF, and TAF

TAF DRUG

Tablets administered without regard to food

Lenacapavir, F/TAF, and TAF

BIC DRUG

Tablets administered without regard to food

Lenacapavir, F/TAF, and BIC

B/F/TAF DRUG

Tablets administered without regard to food

Also known as: Biktarvy®

B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (53)

Valleywise Community Health Center - McDowell

Phoenix, Arizona, 85004, United States

Location

Pueblo Family Physicians

Phoenix, Arizona, 85015, United States

Location

Ruane Clinical Research Group Inc

Los Angeles, California, 90036, United States

Location

Mills Clinical Research at Men's Health Foundation

Los Angeles, California, 90069, United States

Location

Eisenhower Health Center at Rimrock

Palm Springs, California, 92264, United States

Location

University of Colorado, Denver, University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Public Health

Denver, Colorado, 80204, United States

Location

Yale University; School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Whitman-Walker Institute, Inc.

Washington D.C., District of Columbia, 20009, United States

Location

Washington Health Institute

Washington D.C., District of Columbia, 20017, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

Floridian Clinical Research

Hialeah, Florida, 33016, United States

Location

AHF-The Kinder Medical Group

Miami, Florida, 33133, United States

Location

AIDS Healthcare Foundation - South Beach

Miami Beach, Florida, 33140, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803-1851, United States

Location

St. Joseph's Hospital Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33401, United States

Location

Atlanta ID Group, PC

Atlanta, Georgia, 30309, United States

Location

August University Medical Center

Augusta, Georgia, 30912, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Mercer University, Department of Internal Medicine

Macon, Georgia, 31201, United States

Location

Chatham County Health Department

Savannah, Georgia, 31401, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Northstar Healthcare

Chicago, Illinois, 60657, United States

Location

Indiana University Infectious Diseases Research

Indianapolis, Indiana, 46077, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

St. John Newland Medical Associates

Southfield, Michigan, 48075, United States

Location

KC CARE Health Center

Kansas City, Missouri, 64111, United States

Location

AHF-Midtown

New York, New York, 10001, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

East Carolina University, The Brody School of Medicine

Greenville, North Carolina, 27858, United States

Location

Rosedale Infectious Diseases

Huntersville, North Carolina, 28078, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Clinical Research Site/University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

St Hope Foundation

Bellaire, Texas, 77401, United States

Location

Prism Health North Texas

Dallas, Texas, 75208, United States

Location

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, 75246, United States

Location

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

The Crofoot Research Center, Inc.

Houston, Texas, 77098, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

Annandale, Virginia, 22003, United States

Location

Peter Shalit, M.D.

Seattle, Washington, 98104, United States

Location

MultiCare Rockwood HIV Critical Care Clinic

Spokane, Washington, 99204, United States

Location

Instituto Dominicano de Estudios Virológicos (IDEV)

Santo Domingo, 10103, Dominican Republic

Location

Clinical Research Puerto Rico

San Juan, 00909-1711, Puerto Rico

Location

HOPE Clinical Research

San Juan, 00909, Puerto Rico

Location

Proyecto ACTU, School of Medicine, University of Puerto Rico

San Juan, 00935, Puerto Rico

Location

Related Publications (10)

• 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.

  PMID: 36566079 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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: randomized study. AIDS. 2025 Oct 7. doi: 10.1097/QAD.0000000000004372. Online ahead of print.

  PMID: 41056006 DERIVED

• 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.

  PMID: 34358495 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

lenacapavir; emtricitabine tenofovir alafenamide; imidazole mustard; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 29, 2019
• Study Start: November 22, 2019
• Primary Completion: October 5, 2021
• Study Completion: September 19, 2023
• Last Updated: October 2, 2024
• Results First Posted: December 19, 2022

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

PR (3); US (49); DO (1)