Conditions: HIV Infections
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 85
Healthy volunteers: no

Brief 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of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program.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.

Detailed description:

Arms:
arm 1: In this pharmaco-kinetic (PK) cross-over design trial, all patients initially receive nevirapine immediate release and then all patients are switched to nevirapine extended release 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).

Interventions: intervention 1: Nevirapine Immediate Release (IR) intervention 2: Nevirapine Extended Release (XR)
Intervention descriptions: intervention 1: 200 mg Tablet or 50 mg / 5 ml oral suspension intervention 2: 200 mg, 300 mg or 400 mg Tablet formulation

Protocol document: