CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Raltegravirdrug
Likely dose
Raltegravir 12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01751568
NCT01751568Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 18, 2012·Updated Nov 5, 2021

In Brief

A Phase 2 clinical trial evaluating Raltegravir for HIV Infections and Tuberculosis. Completed, enrolled 40 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Tuberculosis
CountriesSouth Africa
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2012
Enrollment StartNov 12, 2014
Primary CompletionNov 27, 2019
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 13.5 years ago

Interventions

Raltegravirdrug

Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily.