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P1093: Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

About this study

This study is being done to study a new antiretroviral HIV medication called dolutegravir. This drug is a type of medicine called an integrase inhibitor. Integrase inhibitors work by blocking integrase, a protein that HIV needs to enter human cells and make more copies of itself. The study will help find the best amount or dose of dolutegravir for children and teenagers, when it is taken on its own as well as with other antiretroviral medications. This study will also find out the safety of using this medication in children and adolescents and if there are any side effects from the medication. Dolutegravir has been tested in adults and children. The FDA has approved dolutegravir for use in adults and in children 12 years and older who weigh at least 40 kilograms (about 88 pounds).

Objectives

  • This study will find out the safety of using this medication dolutegravir in children and adolescents and if there are any side effects from the medication.
  • The study will help find the best amount or dose of dolutegravir for children and teenagers, when it is taken on its own as well as with other antiretroviral medications.

Eligibility

  • At least 4 weeks old but younger than 18 years old.
  • Confirmed HIV-1 infection
  • Current or past treatment with HIV medications (Children younger than 2 years old may be eligible even if they have not been treated with HIV medications.)

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Overview

Study goal:

To find the best amount or dose of dolutegravir for children and teenagers, when it is taken on its own as well as with other antiretroviral medications

Diagnosis:

HIV

Age:

At least 4 weeks old but younger than 18 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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