The HIV epidemic represents one of the greatest health challenges worldwide, with important social and economic implications for public health. Although combination antiretroviral therapy (TAR) is effective in controlling infection and delaying disease onset, as well as improving the quality of life of infected persons, the relevant medical needs caused by HIV-1 infection are not yet fully met by TAR. The main obstacle to curing HIV is the establishment and maintenance of the viral reservoir. Therefore, we believe that this clinical trial will provide knowledge, for the first time, of the increase of antiretroviral drug levels in lymphatic tissue achieved by simultaneous administration of antiretroviral drugs at higher than usual doses, and their effect on persistent viral replication in intestinal lymphatic tissue and, as a consequence, on the latent cellular reservoir of HIV.
Patients who, after receiving information about the study design, the aims of the study, the possible risks that may arise from it and the fact that they can refuse to collaborate at any time, give written consent to participate in the study.
Be over 18 years of age and under 60 years of age.
Understand the purpose of the study and be available to perform the visits and procedures established in the protocol.
Persons with HIV being followed up in HIV consultations.
Chronic Hepatitis B (HBsAg +)
Untreated chronic hepatitis C
Viral tropism X4
Pregnancy or planning to become pregnant during the course of the study.
Parallel
Standardised triple antiretroviral therapy
Drugpatients have to use Triple therapy antiretroviral drugs on their usual regimen containing an integrase inhibitor. There are many types of drugs within this group, so they are not specified.
High doses Triple therapy antiretroviral drugs
Drugdolutegravir 50 mg/12 h, maraviroc 300 mg/12 h and lamivudine 300 mg/12 h
To evaluate the variation in the size of the latent cellular reservoir of HIV-1 in lymphoid tissue and peripheral blood after administration of high doses of antiretroviral drugs.
Latent cell reservoir size by measuring total and intact proviral DNA (IPDA).
To evaluate the variation of intracellular HIV RNA in total CD4+ T cells and memory phenotypes from baseline to weeks 24 and 48 in both blood and lymphoid tissue.
HIV replication by measuring cell-associated HIV RNA (ca-HIV-RNA) and HIV RNA levels in blood and lymphoid tissue.
To compare changes in distribution and activation markers ( CD25, HLA-DR among others) in T-cell subpopulations (naïve and memory phenotypes).
Activation/inflammation markers (HLA-DR, CD25, among others) in blood and intestinal T-cell subpopulations.
To evaluate the effects of the intervention on markers of inflammation and bacterial translocation.
Levels of plasma biomarkers of activation/inflammation and bacterial translocation (IL-6, CRP, TNF, sCD14, among others).
To determine antiretroviral drug concentrations in blood and gastrointestinal tract tissue.
Antiretroviral drug concentrations in lymphoid tissue and peripheral blood.
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