Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study / 中华医学杂志(英文版)

BACKGROUND@#Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.@*METHODS@#We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.@*RESULTS@#At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.@*CONCLUSIONS@#The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.@*TRIAL REGISTRATION@#ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.

Bilateral Peripheral Facial Paralysis Combined with HIV Meningitis During Acute HIV-1 Infection: A Case Report / 中国医学科学杂志(英文版)

Here we reported a Chinese case of bilateral peripheral facial paralysis (PFP) in human immunodeficiency virusc (HIV) infected population. A 38-year-old homosexual male patient was referred to our hospital for bilateral facial paralysis. 21 days prior to admission he had developed high fever, chills, headache, fatigue, general malaise, nausea and vomiting. Neurological examination revealed bilateral ptosis of lower lip and cheeks, as well as failure of bilateral eyes closure. Analysis of cerebrospinal fluid (CSF) revealed pleocytosis, a marked rise of micro total protein and a marked rise of intrathecal lgG synthesis. The result of HIV-1 serology was positive by ELISA and that was confirmed by western blot. His CD4 cell count was 180 cells/mm . HIV-1 viral load in CSF was almost 10 times higher than that in plasma. The patient's condition improved steadily and experienced complete resolution of bilateral PFP after 2 months.

Study on quality of life of asymptomatic HIV infected persons with traditional Chinese medicine / 中国中药杂志

<p><b>OBJECTIVE</b>Study on quality of life of asymptomatic HIV infected persons with traditional Chinese medical, which can provide the clinical basis for improving the quality of life.</p><p><b>METHOD</b>This study applied a randomized, double-blind, and placeb-parallel control designed method to select 1 200 persons in the asymptomatic period of HIV infection as the subjects. The subjects were randomly divided into the treatment group and the control group at the ratio of about 2:1. According to the results of monthly differential diagnosis of TCM, the test group and the control group were given homologue Chinese drugs preparations and model Chinese drugs. The total study period was 18 months. Using PRO scale and the world health organization AIDS determination of quality of life short scale form (WHOQOL-HIV-BREF) to investigate asymptomatic HIV infected persons, according to different times, we calculated the total score and each domain score of quality of life of the treatment group and control group, we did statistical analysis.</p><p><b>RESULT</b>Form the PRO scale,we can see that the treatment group showed a trend of stability, compared with the control group with significant statistical difference (P < 0.05) after 6 months; from the WHOQOL-HIV scale analysis, we can see that compared with before treatment, the quality of life of the treatment group was increased, the difference was significant (P < 0.05), but the quality of life of the control quality of life was decreased, the differences was significant (P < 0.05).</p><p><b>CONCLUSION</b>Dialectical therapy of Chinese medicine can significantly improve the patient's quality of life, which can provide the basis for the prevention and control policy formulation and implementation with asymptomatic HIV infected persons.</p>

Relationship of CD4+ CD25hi regulatory T (Treg) cells to disease progression in HIV-infected patients / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>Analyzing the relationships between peripheral blood CD4+ CD25hi regulatory T (Treg) cells and peripheral blood immune status or plasma HIV-lviral load in HIV-infected individuals,so as to determine whether Treg were related to the progression of HIV-infected disease.</p><p><b>METHODS</b>116 HIV-infected patients in different stages and 21 healthy control individuals were included in this study. The CD4+ and CD8+ T cell counts were determined by a standard 4-color flow cytometry technique. The Treg cells were examined with 3-color immune staining flow cytometry. The plasma HIV-1 viral load was detected by real time PCR.</p><p><b>RESULTS</b>The frequencies of Treg cells decreased in HIV-infected individuals with high CD4+ T cell counts( > 300/microl) compared with normal controls. With the progression of disease the frequencies of Treg cells were raised gradually, until were increased in HIV-infected individuals with low levels of CD4+ T cell counts ( < 100/microl). In addition, the frequencies of Treg cells were inversely related to CD4+ T cell counts and CD4+ /CD8+ ratio, data showed a statistically significant (respectively, r = -0.564, P < 0.001; r = -0.377, P < 0.001). Furthermore, the proportions of Treg cells were closely related to plasma HIV-1 RNA viral load (r = 0.514, P < 0.001).</p><p><b>CONCLUSION</b>CD4 CD25hi Treg cells should be a kind of important cells participating the immunopathogenesis of AIDS. It may play different roles in different stages of HIV-infected disease. The exact mechanism of Treg cells in the progression of the HIV-infected disease needs to be investigate further.</p>

Specific T-cell responses to Mycobacterium tuberculosis protein ESAT-6 in Chinese HIV positive individuals / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To detect TB specific T cell responses by using the recombinant ESAT-6 protein as stimulus in Chinese HIV infected patients.</p><p><b>METHODS</b>ELISPOT-IFN-gamma assay by using the recombinant ESAT-6 protein as stimulus to detect specific T cell responses in HIV+ patients with or without clinical manifestation of TB diseases.</p><p><b>RESULTS</b>Recombinant ESAT-6 protein specific T cell responses show significant high frequencies in both of TB patients with or without HIV infection than that in the healthy control and HIV+ group without clinical TB diseases.</p><p><b>CONCLUSION</b>The ELISPOT-IFN-gamma assay by using recombinant ESAT-6 protein as stimulus could be used in diagnoses of TB infection in Chinese HIV infected patients.</p>

Study on the association of clinical characteristic, CD4+ and level of HIV viral load among 690 initial HIV-infection / 中华流行病学杂志

<p><b>OBJECTIVE</b>To understand the correlation between CD4+ cell count, HIV viral load (VL) and clinical characteristics among patients when HIV-1 was tested positive and initial AIDS diagnosis was made.</p><p><b>METHODS</b>690 HIV-infected cases from Beijing Di-Tan Hospital were included and under a cross sectional study while SPSS statistical method was used.</p><p><b>RESULTS</b>The 690 HIV-infected cases would include 458 males and 232 females with age range from 2-72 years (mean age as 35.3). The modes of transmission showed that: homosexual contact taking up 17.5% while heterosexual was 16.7%. Most of the homosexual-infected ones lived in Beijing and most of them had bachelor or master's degrees. 19.4% of the transmission happened between heterosexual/bisexual couples, suggesting that HIV was transmitted through the "bridge population" while the rest were infected by contaminated blood/plasma. Many of the cases were identified when they lately visited the pre-operation surveillance point in the hospital. Serious immunodeficiency symptoms or signs were discovered as: CD4+ count < 50 cell/microl, serious opportunistic infections including pneumocystosis pulmonary, cerebral toxoplasmosis and cryptococcal meningitis. Higher frequencies of diseases seen were dermotosis, pneumonia, upper respiratory tract infection, hepatitis and digestive tract moniliasis.</p><p><b>CONCLUSION</b>Because of the late identification of the disease, serious immuo-suppression situation often appeared, suggesting that there was an urgent need to improve STD/AIDS knowledge on those HIV (+) people so they might have an early access to accept medical care.</p>

Epidemiologic study and HLA analysis of highly exposed to HIV but persistently seronegative subjects (HEPS) in commercial blood donors in China / 中华实验和临床病毒学杂志

<p><b>BACKGROUND</b>To investigate epidemiology and HLA typing of highly exposed to HIV but persistently seronegative subjects (HEPS) in commercial blood donors in China.</p><p><b>METHODS</b>This was a cohort study for epidemiologic characteristics of highly exposed but persistently seronegative subjects. PCR with sequence-specific primer and PCR-SSP for HLA typing were applied.</p><p><b>RESULTS</b>Eight HEPS were identified. Compared HLA typing with seropositive couple, high frequency of HLA-a24, HLA-B40 genotyping was observed.</p><p><b>CONCLUSION</b>Highly exposed to HIV but persistently seronegative subjects in commercial blood donors in China had high frequency of HLA-A24 and HLA-B40 genotype.</p>