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Clinical Trial Summary

Development of tolerable and effective antiretroviral (ARV) drugs for use in children and adolescents remains a high priority. First-line therapy with non-nucleoside reverse transcriptase inhibitors (NNRTIs) has proven to be effective for HIV-1-infected infants, children, and adolescents. This study will evaluate the safety, effectiveness, and dosing levels of the NNRTI rilpivirine (RPV) when given with two other ARV drugs in treatment-naive, HIV-1-infected children less than 12 years of age.

Clinical Trial Description

This study will enroll HIV-1-infected children less than 12 years of age who are naive to antiretroviral therapy (ART) (have never taken ARV drugs). Study participants will be assigned to 1 of 2 cohorts based on age. Cohort 1 will include children at least 6 years of age to less than 12 years of age. Cohort 2 will include children at least 2 years of age to less than 6 years of age. Each cohort will consist of two stages: Stage 1 and Stage 2. Stage 1 will be the initial dose finding stage. Participants will begin treatment with daily RPV and 2 nucleoside reverse transcriptase inhibitors (NRTIs). The 2 NRTIs will be selected by the site investigator but will not be provided through the study. This stage of the study will involve intense pharmacokinetic (PK) sampling to evaluate the safety, tolerability, and antiviral activity of RPV, which will allow for the selection of an RPV dose to use in Stage 2 of the study. Participants in both cohorts will remain on RPV-based therapy for up to 48 weeks.

Study enrollment will begin with Cohort 1. Once data from Cohort 1 has been reviewed and an RPV dose has been approved, enrollment for Cohort 2 will begin.

Study participation will include at least 12 study visits over 48 weeks. Participants who complete 48 weeks of RPV treatment and are benefiting from the drug will continue on the study and receive RPV as part of a long-term safety follow-up for a minimum of 4 additional years. Study visits in this stage of the study will occur every 24 weeks.

At most visits, participants will give a medical history and undergo a physical exam, blood collection, and urine collection. At some visits, participants will also undergo an electrocardiogram (ECG), adrenocorticotropic hormone (ACTH) stimulation test (consisting of blood collection and an injection of ACTH), and determination of the participant's stage of sexual development. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT01975012
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2014

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