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Increase in 2-long terminal repeat circles and decrease in D-dimer after raltegravir intensification in patients with treated HIV infection : a randomized , placebo-controlled trial . BACKGROUND The degree to which human immunodeficiency virus ( HIV ) continues to replicate during antiretroviral therapy ( ART ) is controversial . We conducted a randomized , double-blind , placebo-controlled study to assess whether raltegravir intensification reduces low-level viral replication , as defined by an increase in the level of 2-long terminal repeat ( 2-LTR ) circles . METHODS Thirty-one subjects with an ART-suppressed plasma HIV RNA level of < 40 copies/mL and a CD4 ( + ) T-cell count of ≥350 cells/mm ( 3 ) for ≥1 year were randomly assigned to receive raltegravir 400 mg twice daily or placebo for 24 weeks . 2-LTR circles were analyzed by droplet digital polymerase chain reaction at weeks 0 , 1 , 2 , and 8 . RESULTS The median duration of ART suppression was 3.8 years . The raltegravir group had a significant increase in the level of 2-LTR circles , compared to the placebo group . The week 1 to 0 ratio was 8.8-fold higher ( P = .0025 ) and the week 2 to 0 ratio was 5.7-fold higher ( P = .023 ) in the raltegravir vs. placebo group . Intensification also led to a statistically significant decrease in the D-dimer level , compared to placebo ( P = .045 ) . CONCLUSIONS Raltegravir intensification resulted in a rapid increase in the level of 2-LTR circles in a proportion of subjects , indicating that low-level viral replication persists in some individuals even after long-term ART . Intensification also reduced the D-dimer level , a coagulation biomarker that is predictive of morbidity and mortality among patients receiving treatment for HIV infection .
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Outcome_Physical
low-level viral replication
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Outcome_Physical
2-long terminal repeat
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Participant_Condition
HIV infection