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IMPAACT2036: Study of long-acting injectable treatment for HIV

Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

Category:

HIV Studies

Diseases Treated:

HIV infection

Eligibility Overview:

  • 2–11 years old
  • Body weight greater than 10 kg but less than 40 kg
  • Confirmed HIV infection
  • Receiving antiretroviral therapy (ART) using 2 or more drugs from 2 or more antiretroviral drug classes for at least 6 months
  • Has not switched ART regimens due to treatment failure
  1. Antiretroviral therapy (ART) in children traditionally consists of a once-daily, single-tablet administration of medications to induce viral suppression. But young children with HIV may have difficulty swallowing tablets. Due to their continual growth and weight gain, they may require periodic adjustments to weight-based ART dosing. This is problematic for the production of single, fixed-dose formulations containing multiple antiretroviral medications, which would require adjustments as the child grows.

    Prior studies have established the dosing, safety, tolerability, and pharmacokinetics of oral and CAB LA (long acting) + RPV LA in adults. The FDA has approved the use of CAB LA plus RPV LA given intramuscularly every 4 or 8 weeks for the treatment of HIV in eligible adolescents and adults in the United States. This treatment approach has demonstrated favorable safety and acceptability outcomes.

    The use of long-acting, injectable HIV medications may offer several advantages as a desirable treatment approach for children and their parents. The IMPACT2036 study will test CAB and RPV pills swallowed whole or dissolved in a liquid (for the smallest children) as well as CAB and RPV injections. The pills will be administered once daily. Injections will be given intramuscularly every month or every 2 months, based on information collected in the study.

    Primary objectives

    • To assess the weight-band dosing, tolerability, and pharmacokinetics of oral CAB + oral RPV followed by injectable CAB LA + RPV LA in virologically suppressed children living with HIV-1, ages 2 to less than 12 years old.
    • To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oral and injectable)
    • Establish if virologically suppressed children living with HIV-1 remain suppressed upon the 2-drug intramuscular (IM) regimen of CAB LA + RPV LA.

    Eligibility criteria

    Inclusion criteria include:

    • 2–11 years old
    • Body weight greater than 10 kg but less than 40 kg
    • Confirmed HIV infection
    • Receiving antiretroviral therapy (ART) using 2 or more drugs from 2 or more antiretroviral drug classes for at least 6 months
    • Has not switched ART regimens due to treatment failure

    Exclusion criteria include:

    • Exceeds acceptable levels of HIV in the body
    • Known or suspected resistance to the integrase strand transfer inhibitor (INSTI) class of ART drugs.
    • Congestive heart failure, arrhythmia, cardiac disease
    • Hepatitis C infection, hepatic disease
    • Current or anticipated need for chronic anti-coagulation
    • Bleeding disorder
    • Sensitivity of heparin or history of heparin-induced thrombocytopenia
    • Risk factors for Torsade de Pointes
    • History of seizures
    • Elevated bilirubin
    • Active tuberculosis infection
    • Pancreatitis
    • Active COVID-19 infection

    Study Sites

    St. Jude Children’s Research Hospital and other sites worldwide

  2. About this study

    People with HIV usually take a combination of drugs every day to stay healthy. This therapy is known as antiretroviral therapy (ART). It prevents HIV from growing in the body. The treatments come in several forms such as liquids, pills, or shots (injections).

    But there are several problems for young children with HIV who take ART pills. They may have trouble swallowing tablets every day. The dose they take is based on how much they weigh. Because they are growing and gaining weight, their dose may need adjusting. Because their pills contain a combination of medicines, this makes it harder to adjust the dose.

    A shot (injection) given in the muscle may be easier for children to take because it lasts longer in the body and they can take it less often than a daily pill. Earlier studies used injections of CAB (cabotegravir) and RPV (rilpivirine) in teens and adults. These shots were safe and effective in these patients. The shots were approved by the FDA to treat HIV in teens and adults, but the medicines have not yet been tested in children.

    This study will test 2 ART drug treatments that fight HIV. Children 2–11 years old will be given CAB and RPV as pills and long-acting shots. We will test 2 groups of children, who will stop taking their current medicines when entering the study:

    1) Group 1: This group of children will take CAB and RPV pills swallowed whole or dissolved in a liquid (for the smallest children) as well as CAB and RPV shots. The pills will be taken every day for 1 month. After testing blood samples in the lab, your child may be able to have CAB and RPV shots instead every 1 or 2 months for about 1 year and 4 months.

    2) Group 2: Your child will stop taking the ART medicines they are taking when they first enter the study. This study will test CAB and RPV pills swallowed whole or dissolved in a liquid (for the smallest children) as well as CAB and RPV shots.

    • Group 2A: This group of children will take CAB and RPV pills swallowed whole or dissolved in a liquid (for the smallest children). The pills will be taken every day for 1 month. At the end of that time, they may be able to get CAB and RPV as shots every 1 to 2 months for about a year.
    • Group 2B: This group of children will start getting the CAB and RPV shots every 1 to 2 months when they first enter the study for about 1 year.

    Purpose of this clinical trial

    • To test the first use of pills dissolved in liquid, as well as CAB and RPV shots in children ages 2–11 years.
    • To study the safety of treatment, how well it works, and if children will accept this type of treatment instead of pills, which they would swallow every day.

    Eligibility overview

    To take part in this study, you must be one of the following:

    • 2–11 years old
    • Body weight more than 10 kg but less than 40 kg
    • Have an active HIV infection
    • On a stable ART treatment for at least 6 months
    • Have not switched ART because the treatment failed
  3. IMPAACT2036 
    Sponsor National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health
    ClinicalTrials.gov identifier

    NCT05660980

    Trial start date January 2024
    Estimated enrollment 90
    Study type Phase I/II
    Conditions HIV
    Ages 2 – 11 years
    Site Principal Investigator Aditya Gaur, MD
    Study site St. Jude Children's Research Hospital
    For a consultation or to discuss St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Aditya Gaur, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

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