The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily. The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily
ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake
Service de maladies infectieuses - CHU Charles de Gaulle
Ouagadougou, Burkina Faso
Service de pédiatrie - CHU Yalgado Ouedraogo
Ouagadougou, Burkina Faso
CEPREF
Abidjan, Côte d’Ivoire
FSU abobo-Avocatier
Abidjan, Côte d’Ivoire
Initial therapeutic cohort: Virological success
survival without virological failure (death or loss of follow-up or virologic failure, i.e. HIV-ARN ≥400 copies/mL on one consecutive sample), analysis of resistance profile.
Time frame: 12 months
Randomised simplification phase: Virological success
survival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25.
Time frame: 25 months
Virological success
HIV RNA \< 400 copies / mL
Time frame: 12 months
Immunological response
CD4+ lymphocyte absolute count and percentage
Time frame: 12 and 25 months
Antiretroviral and cotrimoxazol pharmacokinetic parameters
The following parameters will be measured or calculated: maximal and minimal concentration (Cmax, Cmin), half life (t1/2), Aire Under the Curve (AUC), clearance and volume of distribution, for all antiretroviral (according to treatment arm : AZT, 3TC, LPV, ABC, EFV) and cotimoxazol.
Time frame: 6, 19 and 25 months
Tolerance
occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrome
Time frame: 12 and 25 month
Adherence
measurement at each protocol visit of the three last days treatment intake to be corelated to the antiretroviral concentration and virological success
Time frame: 12 and 25 months
Resistance to antiretroviral
Genotyping to analyse resistance mutation when virological failure
Time frame: 12 and 25 months
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