IMPAACT 1092: Phase IV Evaluation Of The Steady State Pharmacokinetics Of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1-Infected Children

Fecha de inicio: 26 de octubre de 2015

Inclusion Criteria: Documentation of HIV-1 infection defined as positive results from two samples collected at different time points, using protocol-specified tests Meets WHO classification for severe malnutrition, normal nutrition status, or mild malnutrition Eligible for HAART defined by WHO 2013 pediatric guidelines Parent or legal guardian able and willing to provide signed informed consent, remain within the study area during the study period and agree to have subject followed at the clinical site Qualifying hematology and chemistry laboratory values obtained from specimens collected within the study-specific screening period For severely malnourished children: An inpatient in a nutrition rehabilitation unit. Clinical improvement after 10-18 days on nutrition rehabilitation defined as: Appetite returned and eating better - child shows interest in food even if does not complete amount given: No further weight loss Normalized sodium and potassium defined as severity grade 1 or lower No evidence of cardiac failure Loss of apathy and starting to play No hypothermia or pyrexia - temperature stable at >35.0 to <38.0° C (non-axillary) or >34.4 to <37.4° C (axillary) For children with normal - mild malnutrition, clinical stability will be indicated by: Good appetite Normalized sodium and potassium defined as severity grade 1 or lower No hypothermia or pyrexia - temperature stable at >35.0 to <38.0° C (non-axillary) or >34.4 to <37.4° C (axillary) Exclusion Criteria: Edematous malnutrition at the time of study entry ≥ Grade 3 respiratory distress or presence of cardio respiratory compromise within 3 days prior to entry Chemotherapy for malignancy Acute infection for which the child has received appropriate antimicrobial treatment for <5 days Tuberculosis disease Clinic hepatitis as evidenced by jaundice and hepatomegaly Taking any disallowed medications Any condition, situation, or clinical finding that in the opinion of the investigator would place the child at an unacceptable level of risk for injury, or render the child/caregiver(s) unable to meet the requirements of the study, interfere with study participation, or in the interpretation of study results.