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Purpose

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL. - At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL - Plasma HIV-1 RNA levels < 50 copies/mL at screening. - Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows: - A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or - A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or - A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents. - No documented or suspected resistance to bictegravir (BIC). - Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Exclusion Criteria

  • Prior use of, or exposure to, lenacapavir (LEN) - Active tuberculosis infection - Chronic hepatitis B virus (HBV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg 		Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).
  • Drug: Bictegravir
    Tablets administered orally without regard to food
    Other names:
    • GS-9883
  • Drug: Lenacapavir
    Tablets administered orally without regard to food
    Other names:
    • GS-6207
Experimental
Phase 2: BIC 75 mg + LEN 50 mg 		Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
  • Drug: Bictegravir
    Tablets administered orally without regard to food
    Other names:
    • GS-9883
  • Drug: Lenacapavir
    Tablets administered orally without regard to food
    Other names:
    • GS-6207
Active Comparator
Phase 2: Stable Baseline Regimen (SBR) 		Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
  • Drug: Stable Baseline Regimen
    SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). Nucleos(t)ide Reverse Transcriptase Inhibitors: Abacavir Emtricitabine Lamivudine Tenofovir alafenamide Tenofovir disoproxil fumarate Zidovudine Non-Nucleosite Reverse Transcriptase Inhibitors: Delavirdine Efavirenz Nevirapine Rilpivirine Doravirine Integrase Inhibitors: Bictegravir Cabotegravir Dolutegravir Elvitegravir Raltegravir Protease Inhibitors: Atazanavir Darunavir Fosamprenavir Indinavir Lopinavir Nelfinavir Saquinavir Tipranavir Chemokine Co-receptor 5 (CCR5) Antagonist: Maraviroc Fusion Inhibitors: Enfuvirtide gp120 Attachment Inhibitor: Fostemsavir Anti-CD4 Monoclonal Antibodies: Ibalizumab-uiyk
Experimental
Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC) 		Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
  • Drug: BIC/LEN FDC
    Tablets administered orally without regard to food
Active Comparator
Phase 3: Stable Baseline Regimen 		Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.
  • Drug: Stable Baseline Regimen
    SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). Nucleos(t)ide Reverse Transcriptase Inhibitors: Abacavir Emtricitabine Lamivudine Tenofovir alafenamide Tenofovir disoproxil fumarate Zidovudine Non-Nucleosite Reverse Transcriptase Inhibitors: Delavirdine Efavirenz Nevirapine Rilpivirine Doravirine Integrase Inhibitors: Bictegravir Cabotegravir Dolutegravir Elvitegravir Raltegravir Protease Inhibitors: Atazanavir Darunavir Fosamprenavir Indinavir Lopinavir Nelfinavir Saquinavir Tipranavir Chemokine Co-receptor 5 (CCR5) Antagonist: Maraviroc Fusion Inhibitors: Enfuvirtide gp120 Attachment Inhibitor: Fostemsavir Anti-CD4 Monoclonal Antibodies: Ibalizumab-uiyk

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.