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IMPAACT2036: Study of long-acting injectable treatment for HIV

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

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

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

Study goal:

To test the first use of pills dissolved in liquid, as well as CAB and RPV shots in children ages 2–11 years and study the safety of treatment, how well it works, and if children will accept this treatment instead of pills

Diagnosis:

HIV

Age:

2–11 years old

Clinical trials categories:

Human Immunodeficiency Virus (HIV) Infection Infectious Diseases

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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