A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-3vmkt2

Enrollment

Unknown

Registered

2011-06-13

Start date

2010-11-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

Drug: Atazanavir - Powder, Oral, Dosed by weight (5-10 kg = 150 mg, 10-15 kg = 200 mg, 15-20 kg = 250 mg), Once per day, 48 weeks or until a local pediatric ATV approval. Other Names: Reyataz and BMS-

Drug

B20-B24

D27.505.519.389.745.420

Eligibility

Age

3 Months to 5 Years

Inclusion criteria

Inclusion criteria: HIV 1 infection diagnosed by protocol criteria. >= 3 months to 5 to = 1000 copies/mL. Must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country. Subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to at least 2 NRTIs that are approved in their country.

Exclusion criteria

Exclusion criteria: Experienced subjects who received ATV or ATV/RTV at any time prior to study enrollment or who have prior history of 2 or more PI failures. Antiretroviral-naïve or experienced HIV-1 infected patients with contraindication to study medications. Family history of QTc interval syndrome, Brugada syndrome or right ventricular dysplasia or with a corrected QTc interval at screening of > 440 ms. One of the following cardiac rhythm abnormalities documented on the screening ECG: First degree atrioventricular (AV) block as defined by protocol. Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate < 2nd percentile). Use of Tenofovir.

Design outcomes

Primary

Measure	Time frame
The frequency and severity of adverse events, serious adverse events (clinical and laboratory) and discontinuations from study due to adverse events [Time Frame: 48 Weeks].	—

Secondary

Measure	Time frame
Evidence of Viral Load confirmed by HIV-RNA testing [Time Frame: 48 Weeks].	—

Countries

Brazil, Italy, Poland, Russian Federation, South Africa, Thailand, United States

Contacts

Public ContactGlaucia Silva

Bristol-Myers Squibb

glaucia.silva@bms.com+55(11)3882-2165

Outcome results

None listed

Source: REBEC (via WHO ICTRP)