PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) (PRINCE1)
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01099579
First received: April 6, 2010
Last updated: March 28, 2013
Last verified: June 2011
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Purpose
The purpose of this study is to see if atazanavir powder combined with ritonavir are safe and well-tolerated and produced appropriate drug exposure in children ≥ 3 months to < 6 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir 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) 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) |
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 frequency and severity of adverse events, serious adverse events (clinical and laboratory) and discontinuations from study due to adverse events [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evidence of Viral Load confirmed by HIV-RNA testing [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | March 2017 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Atazanavir + Ritonavir |
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:
Drug: Ritonavir
Oral Solution, Oral, 80 mg/mL, Once per day, 48 weeks or until a local pediatric ATV approval
Other Name: Norvir
|
Eligibility| Ages Eligible for Study: | 3 Months to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV 1 infection diagnosed by protocol criteria
- ≥ 3 months to < 5 years and 6 months of age at time of first treatment, and weight > 5 to < 25kg with any screening baseline plasma viral load
- antiretroviral naive and experienced
- Screening HIV RNA ≥ 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. (naives only require a genotpye)
- 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:
- 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 syncope
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099579
Locations
| United States, Tennessee | |
| St Jude Children'S Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Argentina | |
| Local Institution | |
| Buenos Aires, Bs As, Buenos Aires, Argentina, 1141 | |
| Local Institution | |
| Cordoba, Argentina, 5000 | |
| Brazil | |
| Local Institution | |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90020 | |
| Local Institution | |
| Rio De Janeiro, Brazil, 21941 | |
| Chile | |
| Local Institution | |
| Santiago, Metropolitana, Chile, 8380418 | |
| Local Institution | |
| Santiago, Metropolitana, Chile, 000 | |
| Colombia | |
| Local Institution | |
| Cali, Colombia | |
| Italy | |
| Local Institution | |
| Milano, Italy, 20157 | |
| Local Institution | |
| Padova, Italy, 35128 | |
| Local Institution | |
| Roma, Italy, 00165 | |
| Mexico | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44160 | |
| Local Institution | |
| Merida, Yucatan, Mexico, 97000 | |
| Local Institution | |
| Puebla, Mexico, 72000 | |
| Peru | |
| Local Institution | |
| Lima, Peru, 1 | |
| Local Institution | |
| Lima, Peru | |
| South Africa | |
| Local Institution | |
| Bloemfontein, Free State, South Africa, 9301 | |
| Local Institution | |
| Coronationville, Gauteng, South Africa, 2092 | |
| Local Institution | |
| Soweto, Gauteng, South Africa, 2001 | |
| Local Institution | |
| Congella, Kwa Zulu Natal, South Africa, 4013 | |
| Local Institution | |
| Cape Town, Western Cape, South Africa, 7505 | |
| Thailand | |
| Local Institution | |
| Bangkok, Thailand, 10330 | |
| Local Institution | |
| Bangkok, Thailand, 10700 | |
| Local Institution | |
| Chiang Mai, Thailand, 50200 | |
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: | NCT01099579 History of Changes |
| Other Study ID Numbers: | AI424-397, 2009-016361-28 |
| Study First Received: | April 6, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
HIV, Pediatric |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013