Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
NCT ID: NCT00364793
Last Updated: 2014-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2007-02-28
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EFV+ddI+FTC in patients >= 3 months to < 6 months
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
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)
EFV+ddI+FTC in patients >=6 months to < 2 years
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
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)
EFV+ddI+FTC in patients >= 2 years to < 3 years
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
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)
EFV+ddI+FTC in patients >= 3 years to <= 6 years
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
6 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Capital Federal, , Argentina
Local Institution
Cali, , Colombia
Local Institution
Colima, Colima, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Df, Mexico City, Mexico
Local Institution
Morelia, Michioacan, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Puebla City, Puebla, Mexico
Local Institution
San Luis Potosí City, , Mexico
Local Institution
Panama City, , Panama
Local Institution
Bloemfontein, Free State, South Africa
Local Institution
Westdene, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Bangkok, , Thailand
Local Institution
Bangkok, , Thailand
Countries
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References
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Pavia-Ruz N, Rossouw M, Saez-Llorens X, Bunupuradah T, Taylor M, Yang R, Sevinsky H, Krystal M, Lataillade M, Seekins D, Biguenet S. Efavirenz Capsule Sprinkle and Liquid Formulations With Didanosine and Emtricitabine in HIV-1-infected Infants and Children 3 Months to 6 Years of Age: Study AI266-922. Pediatr Infect Dis J. 2015 Dec;34(12):1355-60. doi: 10.1097/INF.0000000000000913.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI266-922
Identifier Type: -
Identifier Source: org_study_id
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