Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir

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.

NCT Number	NCT06640192
Lead Sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions	HIV-1-infection
Enrollment	24 participants
Start Date	2025-05-30
Primary Completion	2026-12 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-25