Starting antiretroviral therapy (ART) in early HIV infection may result in a smaller viral burden in the latently infected pool. To understand whether intensifying ART in early infection leads to improved virologic and immunologic outcomes, investigators (with partial industry funding) conducted an open-label, randomized trial comparing standard boosted protease inhibitor (PI) therapy (tenofovir/FTC + boosted atazanavir or darunavir) with the same regimen plus raltegravir and maraviroc.
Of 40 enrollees, 26 were randomized to five-drug ART and 14 to standard PI-boosted ART. Participants were predominantly men who have sex with men; the mean duration of infection was about 50 days. At baseline, the standard-therapy group had a slightly higher mean viral load than the five-drug group (6.3 vs. 5.6 log copies/mL, respectively) and a slightly lower mean CD4 count (405 vs. 539 cells/mm3), but these differences were not significant.
Participants in the five-drug group achieved an undetectable viral load more rapidly; however, by week 16, 82% of participants in both groups had undetectable viral loads. Of the 34 individuals remaining in the study at week 48, all 11 in the standard-therapy arm and 20 of 23 in the five-drug arm had undetectable plasma HIV RNA levels by both standard reverse-transcriptase polymerase chain reaction and single-copy assay. No significant between-group differences were seen in absolute levels of proviral DNA, changes in cell-associated RNA, levels of naive or central memory CD4 cells, or markers of immune activation (cellular or soluble).
Markowitz M et al. A randomized open-label study of 3- versus 5-drug combination antiretroviral therapy in newly HIV-1–infected individuals. J Acquir Immune Defic Syndr 2014 Jun 1