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Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Sponsor
Gilead Sciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05052996
Collaborator
Merck Sharp & Dohme LLC (Industry)
75
Enrollment
24
Locations
2
Arms
73.9
Anticipated Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
Actual Study Start Date :
Oct 5, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: ISL+LEN

Participants will receive the following for at least 48 weeks: ISL 40 mg and LEN 600 mg on Days 1 and 2 (loading dose) ISL 20 mg and LEN 300 mg on Day 8 and every week thereafter

Drug: ISL
Capsules administered orally without regard to food

Drug: LEN
Tablets administered orally without regard to food
Other Names:
  • GS-6207

    		•
    Experimental: B/F/TAF

    Participants will receive the following for at least 48 weeks: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily After 48 weeks, participants will switch from B/F/TAF to ISL+LEN ISL 40 mg and LEN 600 mg (loading dose over 2 days) ISL 20 mg and LEN 300 mg 7 days after the first loading dose and every week thereafter Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.

    Drug: ISL
    Capsules administered orally without regard to food

    Drug: LEN
    Tablets administered orally without regard to food
    Other Names:
  • GS-6207

    • Drug: B/F/TAF
    Tablets administered orally without regard to food
    Other Names:
  • Biktarvy®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US Food and Drug Administration (FDA)-defined Snapshot Algorithm [Week 24]

    Secondary Outcome Measures

    1. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm [Week 12]

    2. Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm [Week 48]

    3. Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm [Week 12]

    4. Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm [Week 24]

    5. Proportions of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm [Week 48]

    6. Change From Baseline in Clusters of Differentiation 4 (CD4)+ Cell Count at Week 12 [Baseline, Week 12]

    7. Change From Baseline in CD4+ Cell Count at Week 24 [Baseline, Week 24]

    8. Change From Baseline in CD4+ Cell Count at Week 48 [Baseline, Week 48]

    9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation [Up to 5 years]

    10. Pharmacokinetic (PK) Parameter: Cmax of Islatravir (ISL) and Lenacapavir (LEN) [Day 1 up to Week 36]

      Cmax is defined as the maximum observed concentration of drug.

    11. PK Parameter: Tmax of ISL and LEN [Day 1 up to Week 36]

      Tmax is defined as the time (observed time point) of Cmax.

    12. PK Parameter: Ctau of ISL and LEN [Day 1 up to Week 36]

      Ctau is defined as the observed drug concentration at the end of the dosing interval.

    13. PK Parameter: AUCtau of ISL and LEN [Day 1 up to Week 36]

      AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

    14. PK Parameter: t1/2 of ISL and LEN [Day 1 up to Week 36]

      t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening

    • Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening

    • Plasma HIV-1 RNA < 50 copies/mL at screening

    Key Exclusion Criteria:

    • History of prior virologic failure while receiving treatment for HIV-1

    • Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN)

    • Active, serious infections requiring parenteral therapy < 30 days before randomization

    • Active hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory

    • Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.

    • Note: Individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.

    • Any of the following laboratory values at screening

    • Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula

    • Clusters of differentiation 4 (CD4) T cells < 200 cells/mm^3

    • Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration

    • Individuals who plan to continue breastfeeding during the study

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruane Clinical Research Group, Inc Los Angeles California United States 90036
    2 Mills Clinical Research Los Angeles California United States 90069
    3 Washington Health Institute Washington District of Columbia United States 20017
    4 The George Washington University Medical Faculty Associates Inc. Washington District of Columbia United States 20037
    5 Gary J. Richmond, M.D., P.A. Fort Lauderdale Florida United States 33316
    6 Midway Immunology and Research Center Fort Pierce Florida United States 34982
    7 Floridian Clinical Research Miami Lakes Florida United States 33016
    8 Orlando Immunology Center Orlando Florida United States 32803
    9 Emory University Hospital Midtown Infectious Disease Clinic Atlanta Georgia United States 30308
    10 Chatham County Health Department Savannah Georgia United States 31401
    11 Northstar Healthcare Chicago Illinois United States 60657
    12 Community Research Initiative of New England Boston Massachusetts United States 02129
    13 Be Well Medical Center Berkley Michigan United States 48072
    14 Hennepin Healthcare HCMC Minneapolis Minnesota United States 55415
    15 Southampton Healthcare, Inc. Saint Louis Missouri United States 63139
    16 Huntridge Family Clinic Las Vegas Nevada United States 89104
    17 ID Care Hillsborough New Jersey United States 08844
    18 Jacobi Medical Center Bronx New York United States 10461
    19 Philadelphia FIGHT Community Health Centers Philadelphia Pennsylvania United States 19107
    20 Central Texas Clinical Research, LLC Austin Texas United States 78705
    21 AIDS Arms Inc Dallas Texas United States 75208
    22 The Crofoot Research Center, INC Houston Texas United States 77098
    23 Peter Shalit, M.D. Seattle Washington United States 98104
    24 Community Health Care Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Gilead Sciences
    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT05052996
    Other Study ID Numbers:
    • GS-US-563-6041
    First Posted:
    Sep 22, 2021
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 13, 2022