Last updated on August 2019

Evaluating the Safety Tolerance and Pharmacokinetics of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in Infants and Children Infected With HIV and TB

Brief description of study

People who are infected with HIV and tuberculosis (TB) need to receive medications that treat both diseases safely and effectively. This study will enroll infants and children infected with HIV and TB and evaluate the safety and tolerance of an antiretroviral (ARV) treatment regimen for HIV that contains raltegravir when administered with a TB treatment regimen that includes rifampicin. Study researchers will also determine the most effective dose of raltegravir for infants and children when it is taken with rifampicin.

Detailed Study Description

People who are infected with HIV are also at risk for becoming infected with TB, particularly in many resource-limited settings, including Sub-Saharan Africa. Rifampicin is a medication commonly used to treat TB. There is a need for HIV treatment regimens that contain newer ARV medications that are well-tolerated and have minimal interactions with rifampicin-containing TB medication regimens. This study will enroll HIV-infected infants and children who have never taken any ARV medications or who have not received ARVs for at least 30 days prior to study entry and who are infected with TB and are taking or will be starting a TB medication regimen that includes rifampicin. The purpose of this study is to evaluate the safety and tolerance of raltegravir-containing ARV regimens to treat HIV when administered with a rifampicin-containing regimen to treat TB in infants and children. Study researchers will also evaluate the pharmacokinetics of the medications (i.e., how medication is absorbed and processed in the body) and determine the most effective dose of raltegravir when it is administered with a TB regimen that contains rifampicin.

During the study, researchers will continuously monitor participant data for safety and other factors. Researchers may adjust the dose of raltegravir given to participants prior to enrolling additional participants.

At study entry, participants will undergo a medical and medication history review, physical examination, medication adherence assessment, blood collection, and urine collection. Participants will receive chewable raltegravir tablets twice daily, and they will also take their TB medications, including rifampicin, and two nucleoside reverse transcriptase inhibitor (NRTI) ARV medications that will be chosen by participants' doctors. This study will provide raltegravir to participants; all other medications will be prescribed by participants' own doctors.

At a study visit at Days 5 to 8, participants will remain in the clinic for about 12 hours. They will take part in the same study procedures that occurred at the entry visit, but they will also have small amounts of blood collected several times throughout the 12 hours to measure the amount of medication in the blood. After the Day 5 to 8 visit, participants will begin receiving a fourth ARV medication chosen by their doctor, in addition to the other medications. Participants will continue receiving raltegravir until they stop taking their TB medications. They will continue to take the third ARV medication and the other two ARV medications for 3 months after they stop receiving raltegravir and the TB medications.

Additional study visits will occur at Day 14, Weeks 4 and 8, every 4 weeks until the participant stops receiving raltegravir and the TB medications, and 4 and 12 weeks after stopping raltegravir and the TB medications. These study visits will include the same study procedures that occurred at study entry. Participants will be enrolled in the study for a total of about 4 to 9 months.

Clinical Study Identifier: NCT01751568

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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