Study to evaluate and compare anti retroviral tablet formulations for oral fixed dose and solutions in childre

Phase 1

Recruiting

• Conditions: (HIV+); B04.820.650.589.650.350

• Registration Number: RBR-9nq7qd
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Weight between 6.5 and 24.9kg;Confirmed HIV infection; documented by positive results from two samples collected at different times prior to entering the study:Sample # 1 can be tested using:Two rapid tests from two different manufacturers antibodies or based on principles and different antigenic determinants (for larger participants 18 months);An essay EIA OR Western blot OR immunofluorescence assay OR chemiluminescence assay (for larger participants 18 months);A PCR HIV DNA;A quantitative PCR HIV DNA (> 5,000 copies / mL);A qualitative PCR HIV DNA;
A complete test detection of nucleic acids for the HIV virus;2. Sample # 2 can be tested using:An EIA confirmed OR Western blot OR immunofluorescence assay OR chemiluminescence assay (for larger participants 18 months);
A PCR HIV DNA;A quantitative PCR HIV DNA (> 5,000 copies / mL);A qualitative PCR HIV DNA;
A complete test detection of nucleic acids for the HIV virus;In use of highly active antiretroviral therapy (HAART); with stable laboratory tests (viral load and CD4 +) or treatment-naïve;Demonstrate availability and willingness to ingest the drugs studied;
5. Willingness to stay in the hospital for 12 hours for pharmacokinetic study;Parents or legal guardians must be able; agree and are willing to sign the Instrument of Consent;
Female participants; after menarche; must agree to use two forms of contraception from the menarche;Note: female participants with reproductive potential (after menarche) with sexual activity that can result in pregnancy; they must agree to avoid pregnancy in a consistent and appropriate manner with at least two of the following contraceptive methods: condoms; diaphragm or cervical cap with spermicide; IUD; hormonal contraceptives.

Exclusion Criteria

Values outside normal laboratory tests in step 4; according to the DAIDS toxicity table (Annex IV); up to 2 weeks before study entry;Vomiting and diarrhea (greater than grade 2) at least 30 days prior to study entry;Treatment of bacterial; viral or acute severe opportunistic;History of drug toxicity requiring discontinuation of any study drug;Hypersensitivity to drugs under study;medical or surgical problems affecting motility or gastrointestinal absorption (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 clinically significant findings during the medical assessment or physical examination that; in the opinion of the investigator; may interfere with the study;Pregnancy;Failure immune defined as:Incomplete immune response: defined as a failure in subjects with severe immunodeficiency (baseline CD4 percentage <15%) to achieve at least five percentage points increment or children 5 years of age; to increase the absolute value of CD4 . at least 50 cells / mm3 during the first year of treatment;Immune Worsening: defined as the sustained drop of five points in the percentage of CD4 at any age; or fall to values below the absolute number of pretreatment CD4 in children 5 years of age (Brazil; 2009).

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish the comparability kinetic drug AZT (Zidovudine), 3TC (lamivudine) and NVP (Nevirapine) in the pediatric formulation (comrimidos dispersible combined fixed dose) compared to liquid formulations, taking into account pharmacokinetic variability intra and inter volunteers.;Describe any adverse reactions attributed to pediatric formulation under test and the liquid formulation;

Secondary Outcome Measures

Name	Time	Method
Describe parameters pharmacokinetics of AZT parameters (Zidovudine), 3TC (Lamivudine) e NVP (Nevirapine), through blood collection in 14 and 21 days respectively treatment with a Liquid formulations or dispersible tablets combined fixed doses, from hum crossover design ( All the 30 participants will used 14 days liquid formulation and 14 days of dispersible tablets in random order);;Capture all adverse events in each treatment regimen;<br>Proportion of adverse events of grade 3 or 4;