Phase IIIB Pediatric ATV Powder for Oral Use (POU) (PRINCE2)
This study is currently recruiting participants.
Verified April 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335698
First received: April 13, 2011
Last updated: February 22, 2013
Last verified: April 2012
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Purpose
The purpose of this study is to describe the safety, efficacy and pharmacokinetic profile of a regimen consisting of Atazanavir powder boosted with Ritonavir liquid and an optimized dual Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone in pediatric subjects ≥ 3 months to < 8 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Atazanavir Sulphate Drug: Ritonavir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 Nucleoside Reverse Transcriptase Inhibitor (NRTI) Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects Greater Than or Equal to 3 Months to Less Than 8 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE2 Study) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- The number of subjects who died [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
- The frequency of Serious Adverse Events (SAEs) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
- The frequency of Adverse Events (AEs) leading to discontinuation [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportions of subjects with HIV ribonucleic acid (RNA) < 50 c/mL and < 400 c/mL at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- ATV maximum concentration of drug (Cmax) for subjects weighing ≥ 25 - <35 kg and/or aged ≥ 6 - < 8 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
- ATV minimum concentration of drug (Cmin) for subjects weighing ≥ 25 - <35 kg and/or aged ≥ 6 - < 8 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
- ATV area under the curve (AUC) for subjects weighing ≥ 25 - <35 kg and/or aged ≥ 6 - < 8 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Atazanavir+Ritonavir |
Drug: Atazanavir Sulphate
Powder, Oral, Dosed by weight 5- <10 kg = 150 mg, 10- <15 kg = 200 mg, 15- <25 kg = 250 mg, 25- <35 kg = 300 mg, Once daily, 48 weeks or until age of 8 years or weight ≥ 35 kg
Other Names:
Drug: Ritonavir
Solution 80 mg/mL, Oral, Dosed by weight 5- <25 kg = 80 mg, 25- <35 kg = 100 mg, Once daily, 48 weeks or until age of 8 years or weight ≥ 35 kg
Other Name: Norvir
|
Eligibility| Ages Eligible for Study: | 3 Months to 90 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed HIV 1 infection diagnosed by protocol criteria
- Screening HIV RNA ≥ 1000 copies/mL
- ≥ 3 months to < 7 years 6 months of age
- Antiretroviral naive or experienced
- All subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country.
- Antiretroviral-experienced subjects must also have documented 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:
- Experienced subjects who received ATV or ATV/RTV at any time prior to study enrollment or who have prior history of 2 or more protease inhibitor (PI) failures
- Antiretroviral-naïve or experienced HIV-1 infected patients with contraindication to study medications
- Cardiac rhythm abnormalities
- Need for Tenofovir
- Weight < 5kg or ≥35kg
- > Grade 2 aspartate transaminase (SGOT)(AST)/alanine transaminase (SGPT)(ALT)
- Coinfection with either hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Any active Centers for Disease Control and Prevention (CDC) Category C clinical condition
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335698
Hide Study Locations
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Hide Study LocationsLocations
| United States, District of Columbia | |
| Children'S National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Natella Rakhmanina, Site 033 202-884-2130 | |
| United States, New York | |
| Suny Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Leonard B Weiner, Site 038 315-464-6331 | |
| Argentina | |
| Local Institution | Recruiting |
| Buenos Aires, Bs As, Buenos Aires, Argentina, 1141 | |
| Contact: Site 039 | |
| Local Institution | Recruiting |
| Bunos Aires, Buenos Aires, Argentina, 1425 | |
| Contact: Site 001 | |
| Local Institution | Recruiting |
| La Plata, Buenos Aires, Argentina, 1900 | |
| Contact: Site 003 | |
| Brazil | |
| Local Institution | Recruiting |
| Recife, Pernambuco, Brazil, 50070 | |
| Contact: Site 026 | |
| Local Institution | Recruiting |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90020 | |
| Contact: Site 023 | |
| Local Institution | Recruiting |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90035 | |
| Contact: Site 025 | |
| Local Institution | Completed |
| Ribeirao Preto, Sao Paulo, Brazil, 14049 | |
| Local Institution | Recruiting |
| Sao Paolo, Sao Paulo, Brazil, 01246 | |
| Contact: Site 024 | |
| Chile | |
| Local Institution | Recruiting |
| Santiago, Metropolitana, Chile, 000 | |
| Contact: Site 005 | |
| Local Institution | Recruiting |
| Santiago, Metropolitana, Chile, 8380418 | |
| Contact: Site 004 | |
| Mexico | |
| Local Institution | Recruiting |
| Df, Distrito Federal, Mexico, 06720 | |
| Contact: Site 029 | |
| Local Institution | Recruiting |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Contact: Site 020 | |
| Local Institution | Recruiting |
| Guadalajara, Jalisco, Mexico, 44160 | |
| Contact: Site 022 | |
| Local Institution | Recruiting |
| Merida, Yucatan, Mexico, 97000 | |
| Contact: Site 048 | |
| Local Institution | Recruiting |
| Oaxaca, Mexico, 71256 | |
| Contact: Site 030 | |
| Local Institution | Not yet recruiting |
| Puebla, Mexico, 72000 | |
| Contact: Site 021 | |
| Poland | |
| Local Institution | Recruiting |
| Warszawa, Poland, 01-201 | |
| Contact: Site 037 | |
| Puerto Rico | |
| Local Institution | Terminated |
| Rio Piedras, Puerto Rico, 00935 | |
| Romania | |
| Local Institution | Recruiting |
| Bucharest, Romania, 72205 | |
| Contact: Site 017 | |
| Russian Federation | |
| Local Institution | Recruiting |
| Smolensk, Russian Federation, 214006 | |
| Contact: Site 045 | |
| Local Institution | Recruiting |
| St. Petersburg, Russian Federation, 189635 | |
| Contact: Site 018 | |
| Local Institution | Recruiting |
| St.petersburg, Russian Federation, 198103 | |
| Contact: Site 041 | |
| South Africa | |
| Local Institution | Recruiting |
| Port Elizabeth, Eastern Cape, South Africa, 6014 | |
| Contact: Site 043 | |
| Local Institution | Recruiting |
| Bloemfontein, Free State, South Africa, 9301 | |
| Contact: Site 014 | |
| Local Institution | Recruiting |
| Benoni, Gauteng, South Africa, 1501 | |
| Contact: Site 007 | |
| Local Institution | Recruiting |
| Pretoria, Gauteng, South Africa, 0001 | |
| Contact: Site 047 | |
| Local Institution | Terminated |
| Pretoria, Gauteng, South Africa, 0122 | |
| Local Institution | Recruiting |
| Soweto, Gauteng, South Africa, 2001 | |
| Contact: Site 006 | |
| Local Institution | Recruiting |
| Parrow Valley, Western Cape, South Africa, 7505 | |
| Contact: Site 010 | |
| Spain | |
| Local Institution | Recruiting |
| Barcelona, Spain, 08950 | |
| Contact: Site 044 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Site 046 | |
| United Kingdom | |
| Local Institution | Recruiting |
| Birmingham, West Midlands, United Kingdom, B9 5SS | |
| Contact: Site 016 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01335698 History of Changes |
| Other Study ID Numbers: | AI424-451, 2010-024537-23 |
| Study First Received: | April 13, 2011 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Food and Drug Administration South Africa: Medicines Control Council Romania: National Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Chile: Instituto de Salud Publica de Chile Mexico: Ethics Committee Mexico: Ministry of Health Mexico: Secretaria de Salud Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Poland: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: The Central Register of Clinical Trials Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica |
Keywords provided by Bristol-Myers Squibb:
|
Pediatric |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Reverse Transcriptase Inhibitors Ritonavir |
Atazanavir Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 18, 2013