التفاصيل البيبلوغرافية
| العنوان: |
A Randomized Controlled Pilot Trial of Valacyclovir for Attenuating Inflammation and Immune Activation in HIV/Herpes Simplex Virus 2–Coinfected Adults on Suppressive Antiretroviral Therapy. |
| المؤلفون: |
Yi, Tae Joon, Walmsley, Sharon, Szadkowski, Leah, Raboud, Janet, Rajwans, Nimerta, Shannon, Brett, Kumar, Sachin, Kain, Kevin C., Kaul, Rupert, Tan, Darrell H. S. |
| المصدر: |
Clinical Infectious Diseases; Nov2013, Vol. 57 Issue 9, p1331-1338, 8p |
| مصطلحات موضوعية: |
ANTIVIRAL agents, INFLAMMATION, HIV infections, HERPES simplex, RANDOMIZED controlled trials, MEDICAL statistics |
| مستخلص: |
Herpes simplex virus type 2 (HSV-2) coinfection in HIV-infected individuals may contribute to increased systemic inflammation and immune activation that persist despite suppressive antiretroviral therapy. Valacyclovir did not decrease systemic immune activation in HIV-1/HSV-2–coinfected adults on suppressive antiretroviral therapy.Background. Human immunodeficiency virus (HIV) is associated with increased systemic inflammation and immune activation that persist despite suppressive antiretroviral therapy (ART). Herpes simplex virus type 2 (HSV-2) is a common coinfection that may contribute to this inflammation.Methods. Sixty HIV type 1 (HIV-1)/HSV-2–coinfected adults on suppressive ART were randomized 1:1:1 to 12 weeks of placebo, low-dose valacyclovir (500 mg twice daily), or high-dose valacyclovir (1 g twice daily) in this 18-week trial. Co–primary outcome measures were the percentage of activated (CD38+HLA-DR+) CD8 T cells in blood, and highly sensitive C-reactive protein, interleukin 6, and soluble intercellular adhesion molecule 1 in plasma. Secondary outcomes included additional immune, inflammatory cytokine, and endothelial activation markers. The impact of valacyclovir (both groups combined) on each outcome was estimated using treatment × time interaction terms in generalized estimating equation regression models.Results. Participants were mostly white (75%) men who have sex with men (80%). Median age was 51 (interquartile range [IQR], 47–56) years, median duration of HIV infection was 15 (IQR, 8–21) years, median CD4 count at enrollment was 520 (IQR, 392–719) cells/µL, and median nadir CD4 count was 142 (IQR, 42–240) cells/µL. Valacyclovir was not associated with significant changes in any primary or secondary immunological outcomes in bivariate or multivariable models. Medication adherence was 97% by self-report, 96% by pill count, and 84% by urine monitoring. Eight patients had adverse events deemed possibly related to the study drug (5 placebo, 1 low-dose, 2 high-dose), and 6 patients reported at least 1 HSV outbreak (3 placebo, 3 low-dose, 0 high-dose).Conclusions. Valacyclovir did not decrease systemic immune activation or inflammatory biomarkers in HIV-1/HSV-2–coinfected adults on suppressive ART.Clinical Trials Registration. NCT01176409. [ABSTRACT FROM PUBLISHER] |
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| قاعدة البيانات: |
Complementary Index |
