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Lenacapavir Sodium

Lenacapavir Sodium is being studied as a potential new treatment option for people with HIV-1 who are currently on complex treatment regimens. This article explores the ongoing clinical trials that aim to evaluate the safety and effectiveness of Lenacapavir when combined with other HIV medications, particularly for patients who have limited treatment options due to viral resistance or intolerance to existing therapies.

Table of Contents

What is Lenacapavir?

Lenacapavir Sodium, also known as GS-6207, is a new medication being studied for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection. It is being developed by Gilead Sciences Inc. and is currently undergoing clinical trials to evaluate its safety and effectiveness[1].

Medical Condition Treated

Lenacapavir is being studied for the treatment of HIV-1 infection. HIV-1 is a virus that attacks the body’s immune system, making it difficult for the body to fight off infections and diseases. If left untreated, HIV-1 can lead to Acquired Immunodeficiency Syndrome (AIDS)[1].

Study Objectives

The clinical trial for Lenacapavir has several objectives[1]:

Main Objectives:

  • To evaluate the effectiveness of switching to a bictegravir (BIC) + lenacapavir (LEN) regimen compared to continuing on a stable baseline regimen (SBR) in people with HIV-1 who have suppressed viral loads.
  • To assess the efficacy of switching to a BIC/LEN fixed-dose combination (FDC) tablet regimen versus continuing on SBR.

Secondary Objectives:

  • To evaluate the safety and tolerability of the treatment regimens.
  • To study the pharmacokinetics (how the drug moves through the body) of BIC and LEN.
  • To assess changes in CD4 cell count, which is an important measure of immune system health in HIV patients.

Eligibility Criteria

To participate in the Lenacapavir study, patients must meet certain criteria[1]:

Inclusion Criteria:

  • Have documented HIV-1 RNA levels below 50 copies/mL (indicating well-controlled HIV) for at least 6 months prior to screening.
  • Be currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, intolerance, or contraindication to existing single-tablet regimens.
  • Have no documented or suspected resistance to bictegravir.
  • Have an estimated glomerular filtration rate (a measure of kidney function) of ≥ 15 mL/min.

Exclusion Criteria:

  • Prior use of or exposure to lenacapavir.
  • Active tuberculosis infection.
  • Chronic hepatitis B virus (HBV) infection.

Study Endpoints

The study will measure several outcomes to determine the effectiveness and safety of Lenacapavir[1]:

Primary Endpoints:

  • The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at specific time points (24 weeks for Phase 2, 48 weeks for Phase 3).

Secondary Endpoints:

  • The proportion of participants with HIV-1 RNA < 50 copies/mL at specific time points.
  • Changes in CD4 cell count from baseline.
  • The proportion of participants experiencing treatment-emergent adverse events (side effects).
  • Pharmacokinetic parameters of BIC and LEN.

Drug Information

Lenacapavir Sodium is being studied in two forms[1]:

  1. GS-6207 tablets 25 mg: A film-coated tablet containing 25 mg of Lenacapavir Sodium.
  2. GS-6207 tablets 50 mg: A film-coated tablet containing 50 mg of Lenacapavir Sodium.

Both forms are designed for oral use. The maximum daily dose being studied is 25 mg for the 25 mg tablet and 50 mg for the 50 mg tablet. The treatment period in the study is up to 24 weeks[1].

It’s important to note that Lenacapavir is still being studied and is not yet approved for general use. Patients should not attempt to use or obtain this medication outside of a clinical trial setting[1].

Aspect Details
Study Type Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study
Main Objective Evaluate efficacy and safety of switching to Bictegravir/Lenacapavir vs. continuing current complex HIV-1 treatment
Key Inclusion Criteria HIV-1 RNA < 50 copies/mL for ≥6 months, on complex ARV regimen, no resistance to bictegravir
Key Exclusion Criteria Prior use of lenacapavir, active tuberculosis, chronic hepatitis B infection
Primary Endpoints Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 (Phase 2) and Week 48 (Phase 3)
Secondary Endpoints Viral suppression rates, CD4 cell count changes, safety and tolerability, pharmacokinetics of bictegravir and lenacapavir
Treatment Duration Up to 96 weeks for some participants

FAQ

  • What is Lenacapavir Sodium? Lenacapavir Sodium is a new drug being studied for the treatment of HIV-1 infection. It is being tested in combination with other HIV medications, particularly for patients who are on complex treatment regimens due to viral resistance or intolerance to existing therapies.
  • Who is eligible for the Lenacapavir clinical trials? The trials are primarily for people with HIV-1 who have been on a complex antiretroviral regimen for at least 6 months, have no resistance to bictegravir, and have maintained viral suppression (HIV-1 RNA levels below 50 copies/mL) for at least 6 months.
  • What is the main goal of these clinical trials? The main goal is to evaluate the safety and efficacy of switching to a regimen containing Lenacapavir (combined with bictegravir) compared to continuing on the current complex treatment regimen in people with HIV-1 who have achieved viral suppression.
  • How long do the clinical trials last? The trials have different phases. The initial phase lasts 24 weeks, followed by a longer phase that extends up to 48 weeks, with some participants being followed for up to 96 weeks.
  • What are the main outcomes being measured in these trials? The primary outcomes include the proportion of participants with HIV-1 RNA levels above 50 copies/mL at specific time points, changes in CD4 cell counts, and the occurrence of treatment-emergent adverse events. The trials also assess the pharmacokinetics of Lenacapavir and bictegravir.

Ongoing Clinical Trials on Lenacapavir Sodium

  • Study Comparing Bictegravir and Lenacapavir to Current Treatment in Patients with HIV-1 on Complex Regimens

    Not recruiting

    4 1 1 1
    Investigated drugs:
    France Germany Italy Spain

Glossary

  • HIV-1: Human Immunodeficiency Virus type 1, the most common type of HIV that causes AIDS (Acquired Immunodeficiency Syndrome).
  • Antiretroviral (ARV) regimen: A combination of medications used to treat HIV infection.
  • Viral resistance: When HIV mutates and becomes less responsive to certain antiretroviral drugs, making them less effective.
  • Virologically suppressed: When the amount of HIV in the blood (viral load) is reduced to very low levels, typically less than 50 copies/mL, due to effective treatment.
  • CD4 cell count: A measure of the number of CD4 T cells in the blood, which helps assess the health of the immune system in people with HIV.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Fixed-dose combination (FDC): A pill that combines two or more drugs in fixed doses.
  • Adverse events (AEs): Unexpected medical problems that happen during treatment with a drug or other therapy.
  • Glomerular filtration rate: A measure of how well the kidneys are filtering waste from the blood.
  • Snapshot algorithm: A method used by the FDA to analyze HIV treatment efficacy in clinical trials based on viral load measurements at specific time points.

References

  1. http://clinicaltrials.eu/trial/study-comparing-bictegravir-and-lenacapavir-to-current-treatment-in-patients-with-hiv-1-on-complex-regimens/