Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily.
Intervention MeSH terms: Raltegravir Potassium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment