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Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age

NCT01975012 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Rilpivirine

For Cohort 1, Stage 1: RPV will be given orally as a 25-mg film-coated tablet (or for dosing in younger children, as granules \[2.5 mg/g\]) each day with a meal. For Cohort 1, Stage 2: The dose of RPV will be determined once Cohort 1, Stage 1 data are available. For Cohort 2: The dose of RPV will be determined once Cohort 1 data are available.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ann Melvin, MD, MPH · Seattle Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975012 on ClinicalTrials.gov