25701561
BACKGROUND	Early combination antiretroviral therapy ( cART ) initiation at the time of primary HIV-1 infection could restrict the establishment of HIV reservoirs .
BACKGROUND	We aimed to assess the effect of a cART regimen intensified with raltegravir and maraviroc , compared with standard triple-drug cART , on HIV-DNA load .
METHODS	In this randomised , open-label , phase 3 trial , we recruited patients from hospitals across France .
METHODS	Inclusion criteria were primary HIV-1 infection ( an incomplete HIV-1 western blot and detectable plasma HIV-RNA ) , with either symptoms or a CD4 + cell count below 500 cells per L. Patients were randomly assigned ( 1:1 ) to an intensive , five-drug cART regimen ( raltegravir 400 mg and maraviroc 150 mg twice daily , and a fixed-dose combination of tenofovir disoproxil fumarate 300 g plus emtricitabine 200 g , darunavir 800 g , and ritonavir 100 g once daily ) or a standard triple-drug cART regimen ( tenofovir disoproxil fumarate 300 g plus emtricitabine 200 g , darunavir 800 g , and ritonavir 100 g once daily ) using a predefined randomised list generated by randomly selected variable block sizes .
METHODS	The primary endpoint was the median number of HIV-DNA copies per 10 ( 6 ) peripheral blood mononuclear cells ( PBMC ) at month 24 , analysed in the modified intention-to-treat population , defined as all patients who started their assigned treatment .
METHODS	This study is registered with ClinicalTrials.gov , number NCT01033760 .
RESULTS	Between April 26 , 2010 , and July 13 , 2011 , 110 patients were enrolled , of whom 92 were randomly assigned and 90 started treatment ( 45 in each treatment group ) .
RESULTS	Six ( 13 % ) patients in the intensive cART group and two ( 4 % ) in the standard cART group discontinued before month 24 .
RESULTS	At month 24 , HIV-DNA loads were similar between groups ( 235 [ IQR 205-250 ] log per 10 ( 6 ) PBMC in the intensive cART group vs 225 [ 171-255 ] in the standard cART group ; p = 021 ) .
RESULTS	Eight grade 3-4 clinical adverse events were reported in seven patients in the intensive cART group and seven grade 3-4 clinical adverse events were reported in seven patients in the standard cART group .
RESULTS	Three serious clinical adverse events occurred : two ( pancreatitis and lipodystrophy ) in the standard cART group , which were regarded as treatment related , and one event ( suicide attempt ) in the intensive cART group that was unrelated to treatment .
CONCLUSIONS	After 24 months , cART intensified with raltegravir and maraviroc did not have a greater effect on HIV blood reservoirs than did standard cART .
CONCLUSIONS	These results should help to design future trials of treatments aiming to decrease the HIV reservoir in patients with primary HIV-1 infection .
BACKGROUND	Inserm-ANRS , Gilead Sciences , Janssen Pharmaceuticals , Merck , and ViiV Laboratories .

