In May 2016 the well-known scientific journal AIDS Research and Human Retroviruses published the article entitled "Efficacy and Safety of Treatment Simplification to Lopinavir / Ritonavir or Ritonavir Monotherapy: A Randomized Clinical Trial" on the results of the clinical study LOPIDAR, developed by the Fight AIDS Foundation.
The LOPIDAR study, which was carried out between 2009 and 2012 with the participation of patients from the Germans Trias i Pujol Hospital, aimed to demonstrate the efficacy of treatment with the combination of Darunavir/Ritonavir monotherapy compared with the combination Lopinavir/Ritonavir also in monotherapy for a year as a simplification strategy in patients with undetectable viral load and on stable antiretroviral therapy with protease inhibitors or non-nucleoside reverse transcriptase inhibitors (two of the antiretroviral drug families currently used and that operate at different times in the cycle of HIV infection). This comparison had not been studied in any clinical trial previously.
The study, in which 73 patients participated, used the following methodology: participants were randomly divided into two groups, one with the Darunavir/Ritonavir treatment and the other with Lopinavir/Ritonavir. During one year, several follow-up visits were performed to carry out the routine analysis and also to measure drug concentrations in the blood and to determine the viral load and concentrations of drugs in cerebrospinal fluid and semen in a subgroup of patients.
The conclusions of the study, detailed in the published paper, indicate that the two compared treatment strategies seem to be equally effective for virus control and that the difference would be in improved tolerance of therapy with Darunavir/Ritonavir. In the other group, treated with Lopinavir/Ritonavir, patients suffered more gastrointestinal side effects. Only two patients had detectable HIV-1 determinations above 50 copies/ml in the cerebrospinal fluid or semen.