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Report for Clinical Trial NCT01013987

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients.

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.

NCT01013987 HIV-1 Adults Patients AIDS Triple Class Failure

3 Interventions

Name: maraviroc

Description: maraviroc: one 150 mg pill twice daily
Type: Drug

Name: Raltegravir

Description: raltegravir : one 400 mg pill twice daily
Type: Drug

Name: Darunavir/ritonavir

Description: darunavir : two 300 mg pills twice daily with meal ritonavir: one 100 mg pill twice daily with meal
Type: Drug

Primary Outcomes

Measure: Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24

Time: week 24

Secondary Outcomes

Measure: Proportion of patients with HIV RNA levels of less than 50 copies/ml at week 24 and with HIV RNA levels of less than 400 copies/ ml at weeks 24 and 48.

Time: week 24 and week 48

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 Q151M

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 ---

HPO Nodes