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

Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Categories:

Infectious Diseases

Phase I/II

Diseases Treated:

Human Immunodeficiency Virus

Eligibility Overview:

  • 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.)

Description

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.)

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).

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

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.