drugset / Trial / NCT00928187

Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)

NCT00928187

RandomizedParallel-groupOpen-labelTreatment

Summary

Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant. This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.

Timeline

Start
2009-11
Primary completion
2013-09
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abacavir Other / unclassified 300 mg
Comparator Darunavir Small molecule 400 mg
Comparator Didanosine Small molecule 250 mg
Comparator Didanosine Small molecule 400 mg
Comparator Lopinavir Other / unclassified 200 mg
Comparator Ritonavir Other / unclassified 50 mg
Comparator Ritonavir Other / unclassified 100 mg
Comparator Tenofovir Small molecule 300 mg
Comparator emtricitabine Other / unclassified 200 mg