MARC details
| 000 -LEADER |
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| fixed length control field |
02944nam a22003377a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
201229s20192019 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
2328-8957 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
31211164 |
| 245 ## - TITLE STATEMENT |
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| Title |
A Phase I, Randomized, Controlled Clinical Study of CC-11050 in People Living With HIV With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE). |
| 251 ## - Source |
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| Source |
Open Forum Infectious Diseases. 6(6):ofz246, 2019 Jun. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Open forum infect. dis.. 6(6):ofz246, 2019 Jun. |
| 253 ## - Journal Name |
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| Journal name |
Open forum infectious diseases |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2019 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2019 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
epublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2020-12-29 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Conclusions: CC-11050 was well tolerated in PLWH, without affecting CD4 counts or plasma viremia, and led to a decrease in NK cells and plasma IL-8 level after 12-weeks of administration. Further study will be needed to elucidate the efficacy of CC-11050 as potential anti-inflammatory adjuvant strategy in HIV. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Method: Thirty PLWH on antiretroviral therapy (ART) >= 1 year with suppressed HIV viremia were enrolled and randomized 2:1 to 12 weeks of CC-11050 200mg twice daily or placebo with follow-up at weeks 2, 4, 8, 12, and 16. Primary endpoint was safety. Secondary endpoints were the effect of CC-11050 on cytokines, monocyte, and T-cell activation and potential pharmacokinetic interaction between CC-11050 and Efavirenz (EFV). |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Objective: Phosphodiesterase 4 inhibitors (PDE4i) are novel anti-inflammatory medications that have been approved for rheumatologic diseases and have been tested as host-directed therapy in tuberculosis. We examined the safety of CC-11050, a potent PDE4i in people living with HIV (PLWH) with suppressed HIV plasma viremia. We hypothesized that CC-11050 could be used to modulate HIV-related inflammation. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Results: At baseline, median age was 49.5 years and CD4 count 459 cells/microL. Most frequent adverse events (grade 1 and 2 only) in CC-11050 group were headache, diarrhea, nausea, cough, nasal congestion, and restlessness. Over a 12-week period, the CC-11050 group had lower level of IL-8, adjusted for baseline level, group, and week (0.72-fold, P = .02), lower percentage of NK cells (0.87-fold, P = .02) and higher IL-6 level (1.48-fold, P = .03) compared to placebo (0.87-fold, P = .02). CC-11050 and EFV co-administration did not reveal any pharmacokinetic interaction. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Medicine/Internal Medicine |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Boulougoura, Afroditi |
| 790 ## - Authors |
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| All authors |
Arakawa K, Boulougoura A, Gabriel E, Gorelick RJ, Higgins J, Khetani V, Kibiy A, Kumar P, Laidlaw E, Lumbard K, Pau A, Poole A, Rupert A, Sereti I |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1093/ofid/ofz246">https://dx.doi.org/10.1093/ofid/ofz246</a> |
| Public note |
https://dx.doi.org/10.1093/ofid/ofz246 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
