AZT-3TC-LPV/r twice a day
DrugAZT 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
NCT Number: NCT01127204
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.
Looking for future studies?
Notify Me3 month–12 month
All sexes
Interventional
Phase 2 / Phase 3
Service de maladies infectieuses - CHU Charles de Gaulle, Ouagadougou, Burkina Faso
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for antiretroviral treatment initiation:
Exclusion criteria
for antiretroviral treatment initiation:
Inclusion criteria
for randomisation at 12 months in the simplification phase:
Exclusion criteria
for randomisation at 12 months in the simplification phase:
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
Time frame: 12 months
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: 25 months
survival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25.
Time frame: 12 months
HIV RNA < 400 copies / mL
Time frame: 12 and 25 months
CD4+ lymphocyte absolute count and percentage
Time frame: 6, 19 and 25 months
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: 12 and 25 month
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 months
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
Genotyping to analyse resistance mutation when virological failure
ANRS, Emerging Infectious Diseases
Other Gov
Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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