(HIV+)
Conditions
Interventions
All 75 participants remained for twenty one consecutive days each tether:
Arm A: dispersible tablet of Efavirenz 100 mg, taken once daily. Total daily dose in accordance with body weight. Continuous
Arm B: oral solution efavirenz 30 mg / ml to dose per body weight, once daily taken. Continuous use for twenty one days
Drug
Sponsors
Universidade Federal de Minas Gerais
Instituto de Tecnologia em Fármacos - Farmanguinhos
Eligibility
Age
3 Years to 13 Years
Inclusion criteria
Inclusion criteria: Age greater than or equal to 3 years and less than 13 years old; weight between 7.5 and 35kg, HIV infection confirmed, documented by positive results from two samples collected at different times prior to entering the study, according to the criteria Sample # 1 below can be tested using rapid tests Two different two or based on different principles and antigenic determinants manufacturers antibodies (only for largest survey participants 18 months); An EIA or western blot assay, or immunofluorescence assay OR chemiluminescence assay (only for largest survey participants 18 months); A PCR HIV DNA; A quantitative PCR HIV DNA (> 5,000 copies / mL); Qualitative PCR DNA of HIV; a complete test of nucleic acid detection for the HIV virus; Sample # 2 can be tested using: a confirmed EIA test or Western blot OR immunofluorescence test or chemiluminescence test (only for largest survey respondents 18 months); a PCR HIV DNA; a quantitative PCR HIV DNA (> 5,000 copies / mL); qualitative PCR HIV DNA, complete testing detection of nucleic acids for the HIV virus; patient using of antiretroviral regimen containing EFV and criteria showing virologic suppression, or Patient with antiretroviral treatment early indication that have a genotyping test indicating absence of mutations to confirm resistance to EFV; Demonstrate availability and willingness to ingest the drugs under study; availability to stay in the hospital for 24 hours for pharmacokinetic study, parents or legal guardians must be able, agree and are willing to sign the consent form Clarified; female participants, after menarche and sexual activity that can result in pregnancy will be guided by the principal investigator, or someone delegated team for him, to avoid pregnancy using at least two contraceptive methods, preferably a hormonal method and another barrier method. The study sponsor will bear the costs of contraceptive methods.
Exclusion criteria
Exclusion criteria: laboratory test values outside the normal range greater than grade 3 according DAIDS Table toxicity (Annex IV), up to 2 weeks prior to study entry or at any time during the study; Vomiting and diarréiadiarreia ( greater than grade 2) 30 days prior to study entry; treatment for bacterial, viral or opportunistic severe acute; History toxicity to drugs requiring discontinuation of any study drug; Hypersensitivity to study medications, medical or surgical problems that affect the motility or absorption gastrointestinal (eg, ileus, ulcerative colitis) or liver function, treatment with experimental drugs within 30 days prior to study entry; any acute hepatitis, chemotherapy for cancer; Any disease or findings clinically significant for the medical assessment or physical examination that, in the opinion of the investigator, may interfere with the study, immune failure defined as: • incomplete immune response: defined as a failure, in patients with severe immunodeficiency (baseline CD4 percentage greater than 15%), to achieve at least five percentage points of growth, or for children 5 years old, to increase the CD4 absolute value of at least 50 cells / mm3 during the first year of treatment. • immune Worsening: defined as the sustained drop of five points on CD4 percentage at any age, or fall to values below the absolute number of CD4 pretreatment in children 5 years old (Brazil, 2009); Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate pharmacokinetic patterns of Efavirenz in children infected HIV older than 3 years and less than 13 years old, weighing from 7.5 to 35 kg;;To evaluate the safety and efficacy of the treatment by the incidence of events adverse clinical and laboratory, and the reduction in CV (viral load) and increase in immune response (CD4 increase); | — |
Secondary
| Measure | Time frame |
|---|---|
| Describe pharmacokinetic parameters Efavirenz through blood sampling for 21 and 42 days respectively by treatment with the liquid formulation or dispersible tablets starting from a crossover design (all 75 participants will use 21 days liquid formulation and 21 days tablets dispersible order Random;;Evaluate the pharmacokinetic variability, intra and inter volunteers (eg, age) of Efavirenz in the pediatric formulation compared to the liquid formulation; describe any adverse reactions attributed to the pediatric formulation testing and liquid formulation by capturing adverse events during the participation of volunteer in the study;; evaluate the influence of genetic polymorphism of CYP 2B6 enzyme in EFZ clearance between Brazilian children; | — |
Countries
Brazil
Contacts
Public ContactAndré Daher
VPPLR- Plataforma de Pesquisa Clínica - FIOCRUZ
Outcome results
None listed