Abstract | BACKGROUND: METHODS: Impact of Integrase-inhibitor DOlutegravir On the viral Reservoir (INDOOR) is a phase 4 open-label clinical trial that randomly included 42 HIV type 1-infected individuals on effective cART: 20 who switched from PI/r-based to DTG-based cART (switch group), and 22 who remained in PI/r-based regimens (control group). We analyzed blood and ileum biopsies to quantify episomal, total, and integrated HIV DNA, cell-associated HIV RNA, residual plasma viremia, T-cell subsets, cell activation, and inflammation markers. RESULTS: There were no related adverse events or treatment discontinuations due to drug intolerance. The HIV reservoir was consistently larger in ileal than in peripheral CD4+ T cells in both groups (P < .01). Residual viremia in plasma decreased in the switch group (P = .03). However, we did not observe significant longitudinal changes in low-level viral replication, total and integrated HIV reservoir, HIV transcription, T-cell maturation subsets, immunoactivation markers, inflammatory soluble proteins, or cellular markers of latently infected cells. CONCLUSIONS: The INDOOR study is the first evaluation of changes in HIV reservoir size in ileum biopsies and in peripheral blood in individuals switched from PI/r- to DTG-based cART. Although this switch was safe and well tolerated, it had no impact on a large array of immunological and inflammatory markers or on HIV reservoir markers in peripheral or in ileal CD4+ T cells. CLINICAL TRIALS REGISTRATION: EudraCT 2014-004331-39.
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Authors | Sara Morón-López, Jordi Navarro, Montse Jimenez, Sofie Rutsaert, Víctor Urrea, Maria C Puertas, Ariadna Torrella, Laura De Clercq, Bibiana Planas Ribas, Cristina Gálvez, Maria Salgado, Linos Vandekerckhove, Julià Blanco, Manel Crespo, Javier Martinez-Picado |
Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
(Clin Infect Dis)
Vol. 69
Issue 8
Pg. 1320-1328
(09 27 2019)
ISSN: 1537-6591 [Electronic] United States |
PMID | 30590412
(Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. |
Chemical References |
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- HIV Protease Inhibitors
- Heterocyclic Compounds, 3-Ring
- Oxazines
- Piperazines
- Pyridones
- dolutegravir
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Topics |
- Anti-Retroviral Agents
(therapeutic use)
- Biopsy
- Female
- HIV
(drug effects, physiology)
- HIV Infections
(drug therapy, virology)
- HIV Integrase Inhibitors
(therapeutic use)
- HIV Protease Inhibitors
(therapeutic use)
- Heterocyclic Compounds, 3-Ring
(therapeutic use)
- Humans
- Ileum
(virology)
- Male
- Middle Aged
- Oxazines
- Piperazines
- Pyridones
- Viremia
(drug therapy)
- Virus Replication
(drug effects)
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