At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multiple Dose, Cross-over Study to Evaluate the Steady-state Pharmacokinetic Parameters of Nevirapine Extended Release Tablets in HIV-1 Infected Children, With an Optional Extension Phase
In Brief
A Phase 1 clinical trial evaluating Nevirapine Immediate Release (IR) and Nevirapine Extended Release (XR) for HIV Infections. Completed, enrolled 85 participants across 10 sites in 4 countries.
Detailed Summary
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from \>=3 to \<18 years of age. This phase I trial is an open-label, multiple dose, non-randomized and cross-over study. Patients who have completed the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program. During this OEP, nevirapine XR safety and efficacy information will be collected.
Study Details
Timeline
Interventions
200 mg Tablet or 50 mg / 5 ml oral suspension
200 mg, 300 mg or 400 mg Tablet formulation