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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00364793 |
The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination With Didanosine and Emtricitabine in HIV-Infected Infants and Children 3 Months to 6 Years of Age. |
Estimated Enrollment: | 32 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
Oral Solution, Capsules or Tablets, Oral, once daily Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg) Didanosine (ddI) 240 mg/m2 (max 400 mg) Emtricitabine (FTC) 6 mg/kg (max 200 mg) Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer); Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first) |
Ages Eligible for Study: | 3 Months to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
Argentina | |
Local Institution | Recruiting |
Buenos Aires, Argentina, 1425 | |
Contact: Site 018 | |
Argentina, Buenos Aires | |
Local Institution | Recruiting |
Capital Federal, Buenos Aires, Argentina, 1245 | |
Contact: Site 020 | |
Mexico | |
Local Institution | Recruiting |
Colima, Mexico, 28019 | |
Contact: Site 004 | |
Local Institution | Recruiting |
Puebla, Mexico, 72000 | |
Contact: Site 008 | |
Local Institution | Recruiting |
Veracruz, Mexico, 91900 | |
Contact: Site 017 | |
Mexico, Distrito Federal | |
Local Institution | Recruiting |
Df, Distrito Federal, Mexico, 06720 | |
Contact: Site 005 | |
Local Institution | Recruiting |
Df, Distrito Federal, Mexico, 04530 | |
Contact: Site 009 | |
Mexico, Jalisco | |
Local Institution | Recruiting |
Guadalajara, Jalisco, Mexico, 44280 | |
Contact: Site 002 | |
Local Institution | Recruiting |
Guadalajara, Jalisco, Mexico, 44520 | |
Contact: Site 006 | |
Mexico, Michioacan | |
Local Institution | Recruiting |
Morelia, Michioacan, Mexico, 58000 | |
Contact: Site 001 | |
Mexico, Nuevo Leon | |
Local Institution | Recruiting |
Monterrey, Nuevo Leon, Mexico, 64460 | |
Contact: Site 003 | |
Panama | |
Local Institution | Recruiting |
Panama, Panama, 5-4087 | |
Contact: Site 019 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI266-922 |
Study First Received: | August 15, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00364793 |
Health Authority: | United States: Food and Drug Administration |
HIV, Pediatric |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Didanosine Emtricitabine |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |