| Full text | |
| Author(s): Show less - |
Vergara, Tania R. C.
;
Samer, Sadia
;
Santos-Oliveira, Joanna R.
;
Giron, Leila B.
;
Arif, Muhammad Shoaib
;
Silva-Freitas, Maria Luciana
;
Cherman, Lia A.
;
Treitsman, Mauro S.
;
Chebabo, Alberto
;
Sucupira, Maria Cecilia A.
;
Da-Cruz, Aldam.
;
Diaz, Ricardo Sobhie
;
Grp, SPARC Working
Total Authors: 13
|
| Document type: | Journal article |
| Source: | EBIOMEDICINE; v. 23, p. 59-67, SEP 2017. |
| Web of Science Citations: | 2 |
| Abstract | |
Trial Design: Open-label, randomised, controlled, pilot proof-of-concept clinical trial. Methods: Participants: Antiretroviral naive adult males with CD4 count >= 350 cells/mm(3). Interventions: Patients were randomised to receive thalidomide 200 mg QD for 3 weeks (Thalidomide group) or not (Control group) and followed for 48 weeks. Objective: We hypothesized that short-term Thalidomide use would reduce HIV related inflammation and HIV replication among antiretroviral naive HIV infected individuals. Outcome: Viral loads, CD4/CD8 counts, ultra-sensitive C-reactive protein (US-CRP), cell activation markers, and plasma lipopolysaccharide (LPS) were analyzed. Randomisation: Unrestricted randomisation. Blinding: No blinding was used. Results: Numbers randomised: Thirty recruited individuals were randomised to Thalidomide (16 patients) or Control (14 patients) groups. Recruitment: Patients were recruited from April 2011 to January 2013. Outcome: Viral loads remained stable in both groups. During thalidomide treatment, a decrease in CD4/CD8 ratio (p = 0.04), a decrease in CD4 count (p = 0.04), an increase in cell activation calculated by the percentage of CD38 (+)/HLA-DR+ CD8 cells (p < 0.05) and an increase in US-CRP (p < 0.01) were observed in the Thalidomide group, with all parameters returning to baseline levels after thalidomide interruption. We confirmed that thalidomide increased HIV replication in vitro of 6 of 7 samples from long-term antiretroviral suppressed individuals. Harms: No class 3/4 adverse events occurred. Conclusions: Short-termuse of thalidomide led to an intense transient increase in T cell activation and inflammation, with a decrease in the CD4(+) cell count without changes to the CD8(+) cell count. We confirmed that thalidomide acts in vitro as a latency reversal agent and speculate that the in vivo results obtained were due to an increase in HIV replication. (C) 2017 The Authors. Published by Elsevier B.V. (AU) | |
| FAPESP's process: | 04/15856-9 - Prospective analysis of the virological and immunological characteristics in individuals with recent HIV-1 infection in the cities of São Paulo and Santos |
| Grantee: | Ricardo Sobhie Diaz |
| Support Opportunities: | Research Projects - Thematic Grants |