drugset / Trial / NCT06640192

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

NCT06640192

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-05-30
Primary completion
2026-12
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg Oral
Subject Lamivudine Other / unclassified 300 mg Oral
Subject Maraviroc Other / unclassified 300 mg Oral