Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB

HIV Infections Clinical Trial

Official title: Phase I/II Dose-Finding, Safety, Tolerance, and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-Infected and TB Co-Infected Infants and Children

Status Completed

Clinical Trial Summary

People who are infected with HIV and tuberculosis (TB) need to receive medications that treat both diseases safely and effectively. This study enrolled infants and children infected with HIV and TB and evaluated 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 aimed to determine the most effective dose of raltegravir for infants and children when taken with rifampicin.

Clinical Trial 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 enrolled HIV-infected infants and children: who had never taken any ARV medications or who had not received ARVs for at least 30 days prior to study entry; and who were infected with TB and were taking or were starting a TB medication regimen that included rifampicin. The purpose of this study was to evaluate the safety and tolerance of raltegravir-containing ARV regimens to treat HIV when administered with a rifampicin-containing regimen used to treat TB in infants and children. Study researchers also evaluated the pharmacokinetics of the medications (i.e., how medication is absorbed and processed in the body) and determined the most effective dose of raltegravir when administered with a TB regimen that contains rifampicin. During the study, researchers continuously monitored participant data for safety and other factors. Researchers could adjust the dose of raltegravir given to a group of participants prior to enrolling additional participants. At study entry, participants underwent a medical and medication history review, physical examination, medication adherence assessment, blood collection, and urine collection. Participants received chewable raltegravir tablets twice daily, and they also took their TB medications, including rifampicin, and two nucleoside reverse transcriptase inhibitor (NRTI) ARV medications chosen by participants' doctors. This study provided raltegravir to participants; all other medications were prescribed by participants' own doctors. At a study visit at Days 5 to 8, participants remained in the clinic for about 12 hours. They took part in the same study procedures that occurred at the entry visit, but they also had 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 began receiving a fourth ARV medication chosen by their doctor, in addition to the other medications. Participants continued receiving raltegravir until they stopped taking their TB medications. They continued to take the third ARV medication and the other two ARV medications for three months after they stopped receiving raltegravir and the TB medications. Additional study visits occurred at Day 14, Weeks 4 and 8, every 4 weeks until the participant stopped receiving raltegravir and their TB medications, and 4 and 12 weeks after stopping raltegravir and the TB medications. These study visits included the same study procedures that occurred at study entry. Participants were expected to participate in the study for a total of about 4 to 9 months. Note that out of the forty (40) participants enrolled only (39) participants received the study treatment (raltegravir). The total enrollment for Cohort 1 was thirteen (13) participants, with only twelve (12) who received raltegravir. Therefore, the results of this submission is based on the 39 participants who received raltegravir. ;

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

• NCT number: NCT01751568
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 12, 2014
• Completion date: November 27, 2019