Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects. The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.
Name: maravirocDescription: maraviroc: one 150 mg pill twice dailyType: Drug
Name: RaltegravirDescription: raltegravir : one 400 mg pill twice dailyType: Drug
Name: Darunavir/ritonavirDescription: darunavir : two 300 mg pills twice daily with meal ritonavir: one 100 mg pill twice daily with mealType: Drug
Single Group Assignment
There is one SNP
Those with evidence of R5 viruses and susceptibility to darunavir in the resistance testing analysis, plus history of failure to NRTIs, NNRTIs and at least one PI, plus a genotype analysis showing evidence of resistance to NRTIs (at least 2 TAMS and/or Q151M and or 69ss), resistance to PIs (at least 2 major mutations), will start a regimen of maraviroc, raltegravir and ritonavir boosted darunavir. --- Q151M ---