The safety and efficacy of PDE5-inhibitors-vardenafil on treating diabetes mellitus erectile dysfunction: A protocol for systematic review and meta analysis.

BACKGROUND: Diabetic mellitus erectile dysfunction (DMED) refers to erectile dysfunction (ED) secondary to diabetes. As people's lifestyle changes and the population ages, the incidence of DMED continues to increase. Many clinical trials have proven that PDE5-inhibitors-vardenafil has a significant effect in the treatment of Diabetic mellitus erectile dysfunction. In this systematic review, we aim to evaluate the effectiveness and safety of PDE5-inhibitors-vardenafil for Diabetic mellitus erectile dysfunction. METHODS: We will search PubMed, Cochrane Library, AMED, EMbase, WorldSciNet; Nature, Science online and China Journal Full-text Database (CNKI), China Biomedical Literature CD-ROM Database (CBM), and related randomized controlled trials included in the China Resources Database. The time is limited from the construction of the library to February 2019.We will use the criteria provided by Cochrane 5.1.0 for quality assessment and risk assessment of the included studies, and use the Revman 5.3 and Stata13.0 software for meta-analysis of the effectiveness, recurrence rate, and symptom scores of Diabetic mellitus erectile dysfunction. ETHICS AND DISSEMINATION: This systematic review will evaluate the efficacy and safety of PDE5-inhibitors-vardenafil for treating Diabetic mellitus erectile dysfunction. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process Trial. TRIAL REGISTRATION NUMBER: PROSPERO CRD42018095185.

[Effect of Hope on Self-efficacy and Self-management in Patients with Chronic Kidney Disease(Stages 1-3)].

Objective To describe the status of hope,self-efficacy,and self-management in patients with chronic kidney disease(CKD)(stages 1-3)and to explore the interactions between these three variables.Methods Herth Hope Index,self-efficacy scale,and CKD self-management instrument were used to evaluate the patients with CKD(stages 1-3)in PUMC Hospital(n=153). Structural equation modeling was used to establish the structural equation model of hope,self-efficacy,and self-management.Results The median score of hope was 40.0(36.0,44.5),and 85.0% of patients were in higher level of hope. The median score of self-efficacy was 8.3(7.1,9.4)and the overall score of self-management was 89.0±13.4. There were no significant differences in level of hope and self-management among patients with different age,gender,marital status,educational level,course of disease,and CKD stages(all P>0.05). Age and marriage status were significantly associated with self-efficacy. Self-efficacy was significantly higher in >65 years group than in other age groups(P<0.05)and was significantly higher in married group than in single group(P<0.05).The level of hope had direct effect on self-efficacy(ß=0.67,P<0.05)and self-management(ß=0.46,P<0.05).Conclusions The levels of hope,self-efficacy,and self-management are high in patients with CKD(stages 1-3). Hope directly affects the self-efficacy and self-management of these patients.

[Safety study of 52-week highly active antiretroviral therapy in 198 HIV/AIDS Chinese patients].

OBJECTIVE: To evaluate the safety profiles of three nevirapine-based therapies for antiretroviral-naive Chinese adults infected with HIV-1 (human immunodeficiency virus-1). METHODS: For this prospective multicentric randomized trial, a total of 198 antiretroviral-naive HIV-1 positive patients were recruited from 13 research centers in China. They were randomly assigned to receive three NVP-based antiretroviral therapies for 52 weeks: Group A, AZT (zidovudine) + DDI (didanosine) + NVP (nevirapine); Group B, D4T (stavudine) + 3TC (lamivudine) + NVP; Group C, AZT + 3TC + NVP. Their clinical events and laboratory examinations were monitored at baseline and the end of weeks 4, 8, 12, 24, 36 & 52 post-HAART (highly active antiretroviral therapy) to evaluate the occurrence of adverse events (AEs). The chi-square or Fisher's exact test was employed to compare the rates of AEs among three treatment groups. Multivariate logistic regression analyses were used to identify the factors associated with hepatotoxicity. For all tests, P < 0.05 was considered as statistically significant. RESULTS: During the 52-week HAART, 968 cases of AEs occurred in 188 patients (95.0%). Only 37.4% experienced grade 3/4 AE. And 37 patients withdrew because of HAART-related AEs (18.7%). The common AEs were hepatotoxicity, bone morrow suppression, gastrointestinal disorders, rash and hyperlipidemia, etc. Most instances of AEs occurred during the early 12 weeks. The total count of AEs for each group had no statistic significant difference (P = 0.403). Bone marrow suppression was more strongly associated with an AZT-containing HAART and it was especially prone to gastrointestinal disorders when combined with DDI. The introduction of D4T or DDI led more frequently to peripheral neuropathy and hyperlipidemia. Logistic regression analysis indicated that presence of hepatotoxicity was associated with a higher baseline level of CD4 (CD4 count > 250/µl) (OR = 2.08, 95%CI: 1.114 - 3.882, P = 0.021). CONCLUSION: The common reasons of discontinuing HAART are hepatotoxicity, gastrointestinal disorders, bone marrow suppression and rash. The occurrence of AEs should be vigorously monitored especially during the early 3 months of HAART. The HIV/AIDS patients with a CD4 count of > 250/µl shall avoid any NVP-containing regimen.

[The impact of highly active antiretroviral therapy on bone mineral density in human immunodeficiency virus infected patients].

OBJECTIVE: To evaluate the influence of highly active antiretroviral therapy (HAART)on bone mineral density(BMD) of human immunodeficiency virus (HIV) infected patients and correlating clinical factors. METHODS: The clinical data from 2007 to 2008 were analyzed, including 50 patients treated with HAART (named treated group), 12 HIV-infected antiretroviral-naive patients (named untreated group) and 20 healthy people (named control group). Lumbar, femoral neck, femur, femoral greater trochanter and whole body BMD were measured by dual energy X-ray absorptiometry. The data were respectively analyzed. RESULTS: There were 19(38.0%) patients with osteopenia and 1 (2.0%) patient with osteoporosis in the treated group. There were 6 (50.0%) patients with osteopenia and 2 (16.7%) patient with osteoporosis in the untreated group. There were 5 (25.0%) patients with osteopenia, no one with osteoporosis in the control group. The prevalence of osteopenia/osteoporosis was statistically higher in the untreated group than that in the control group (P=0.02). The BMD of femur, femoral neck and greater trochanter [(0.97±0.14), (0.91±0.13), (0.76±0.12) g/cm2] in the HIV-infected group (including the treated and untreated group) were significantly lower than that in the control group [(1.04±0.12), (0.98±0.14), (0.84 ± 0.11) g/cm2, P<0.05]. There were no significantly differences in the BMD between the untreated group and the treated group. In the treated group, osteopenia/osteoporosis correlated with body weight less than 60 kg (r=0.074, P=0.004) and the viral load before HAART (r=5.103, P=0.021). CONCLUSIONS: The prevalence of osteopenia and osteoporosis in antiretroviral-naive HIV-infected patients is higher. The BMD of HIV-infected patients are reduced compared with the healthy people. The BMD is similar among HIV-infected patients irrespective of antiretroviral treatment. Body weight less than 60 kg and the viral load before HAART are the risk factors of osteopenia/osteoporosis for the HIV-infected antiretroviral patients.

Longitudinal observation of an interferon gamma-released assay (T-SPOT.TB) for Mycobacterium tuberculosis infection in AIDS patients on highly active antiretroviral therapy.

BACKGROUND: T-SPOT.TB is a novel test for tuberculosis infection with higher sensitivity and specificity than the traditional tuberculin skin test (TST). However, there are no longitudinal data in the literature evaluating T-SPOT.TB for Mycobacterium tuberculosis in patients with acquired immune deficiency syndrome (AIDS) on highly active antiretroviral therapy (HAART). The objective of this study was to assess the value of T-SPOT.TB longitudinally in AIDS patients on HAART without prophylaxis for tuberculosis. METHODS: A prospective observational study was conducted in 50 AIDS patients on HAART. None of the subjects had evidence of active tuberculosis. T-SPOT.TB, a T-cell-based interferon gamma released assay, was performed at the onset of the study and repeated 24 months thereafter. Subjects were evaluated every 6 months during the 36-month follow-up. RESULTS: Twenty-one (42%) AIDS patients on HAART tested positive by T-SPOT.TB (95%CI 28.3% - 55.7%). The pooled spot-forming cells of early secretory antigenic target-6 (ESAT-6) and culture filtrate protein-10 (CFP-10) peptides were 68/million peripheral blood mononuclear cell (PBMC) (interquartile range 44 - 220). The average number of CD4 cells in subjects was (305 +/- 152) cells/microl, and there was no significant difference in T-SPOT.TB response rates between subjects with CD4 cell counts < 200 cells/microl (7/15 (46.7%), 95%CI 21.5% - 71.9%) and those with CD4 cell counts >/= 200 cells/microl (14/35 (40.0%), 95%CI 23.8% - 56.2%, P = 0.662). In the 32 subjects who completed the 24-month follow-up, 10 underwent T-SPOT.TB reversion, one had T-SPOT.TB conversion, six remained positive and 15 remained negative. None of them advanced to active tuberculosis during the 36-month follow-up. CONCLUSION: The inactive status of tuberculosis infection may be maintained for a long period in AIDS patients on HAART.

Impact of baseline CD4(+) T cell counts on the efficacy of nevirapine-based highly active antiretroviral therapy in Chinese HIV/AIDS patients: a prospective, multicentric study.

BACKGROUND: CD4(+) T cell counts have been used as the indicator of human immunodeficiency virus type 1 (HIV-1) disease progression and thereby to determine when to start highly active antiretroviral therapy (HAART). Whether and how the baseline CD4(+) T cell count affects the immunological and viral responses or adverse reactions to nevirapine (NVP)-containing HAART in Chinese HIV-1 infected adults remain to be characterized. METHODS: One hundred and ninety-eight HIV-seropositive antiretroviral therapy (ART)-naive subjects were enrolled into a prospective study from 2005 to 2007. Data were analyzed by groups based on baseline CD4(+) T cell counts either between 100 - 200 cells/microl or 201 - 350 cells/microl. Viral responses, immunologic responses and adverse events were monitored at baseline and at weeks 4, 12, 24, 36, 52, 68, 84, 100. RESULTS: Eighty-six and 112 subjects ranged their CD4(+) T cell counts 100 - 200 cells/microl and 201 - 350 cells/microl, respectively. The pre-HAART viral load in CD4 201 - 350 cells/microl group was significantly lower than that in CD4 100 - 200 cells/microl group (P = 0.000). After treatment, no significant differences were observed between these two groups either in the plasma viral load (pVL) or in the viral response rate calculated as the percentage of pVL less than 50 copies/ml or less than 400 copies/ml. The CD4(+) T cell counts were statistically higher in the 201 - 350 group during the entire follow-ups (P < 0.01) though CD4(+) T cell count increases were similar in these two groups. After 100-week treatment, the median of CD4(+) T cell counts were increased to 331 cells/microl for CD4 100 - 200 cells/microl group and to 462 cells/microl for CD4 201 - 350 cells/microl group. Only a slightly higher incidence of nausea was observed in CD4 201 - 350 cells/microl group (P = 0.05) among all adverse reactions, including rash and liver function abnormality. CONCLUSIONS: The pVLs and viral response rates are unlikely to be associated with the baseline CD4(+) T cell counts. Initiating HAART in Chinese HIV-1 infected patients with higher baseline CD4(+) T cell counts could result in higher total CD4(+) T cell counts thereby achieve a better immune recovery. These results support current guidelines to start HAART at a threshold of 350 cells/microl.

[The clinical outcome and immune reconstitution in 45 advanced AIDS patients undergoing highly active antiretroviral therapy for 12 months].

OBJECTIVE: To investigate the efficacy and side effects of highly active antiretroviral therapy (HAART) in Chinese AIDS patients. METHODS: 45 antiretroviral drug-naive AIDS patients were enrolled and divided into two groups by their baseline CD(4) count < 100/microl or > or = 100/microl. Clinical, virological and immunological outcomes as well as side effects were followed at baseline and at the end of month 1, 3, 6, 9, 12 after receiving HAART. RESULTS: Among the 45 HIV/AIDS patients included, by the end of 12 months of HAART, the plasma viral load (VL) got a mean reduction by 2.8 lg copies/ml, CD(4) count had a mean gain of 187/microl, among which the naive phenotype increased by 68/microl and the memory phenotype by 119/microl. The CD(4)(+)CD(28)(+) T cell percentage went up from (62.5 +/- 25.8)% to (82.6 +/- 15.6)% (P < 0.001); and there was a significant reduction of CD(8)(+) T-cell activation. In the 31 patients with their baseline CD(4) count < 100/microl, 11 had a VL < 50 copies/ml, and 14 had fluctuations in their VL; while in 14 patients with their baseline CD(4) count > or = 100/microl, 10 had a VL < 50 copies/ml and 2 had fluctuations in their VL, respectively, with statistic significance between the two groups. CD(4) count showed a bi-phase increase during HAART and there was significant positive correlation between the change of CD(4) count and plasma VL. Throughout the 12 months of HAART, 39 patients had gastrointestinal side effects, 15 peripheral neuritis, 3 hepatic lesions, 4 hematological side effects and 1 renal calculus. 9 patients had adjustment of their initial therapy because of side effects. CONCLUSIONS: Immune reconstitution as well as significant therapeutic effect was observed in advanced Chinese AIDS patients after HAART. Side effects were common during HAART, so close clinical attention is needed.

Clinical outcomes and immune reconstitution in 103 advanced AIDS patients undergoing 12-month highly active antiretroviral therapy.

BACKGROUND: Highly active antiretroviral therapy (HAART) produces profound suppression of HIV replication, substantial increase in CD4(+) T cells, and partial reconstitution of the immune system. However, the numbers of subjects were small in previous Chinese studies. This study evaluated the efficacy and side effects of HAART in Chinese advanced AIDS patients. METHODS: One hundred and three antiretroviral drug naive AIDS patients were enrolled in this study and were divided into two groups by their baseline CD4(+) count: < 100 cells/microl or > or = 100 cells/microl. Clinical, virological and immunological outcomes were monitored at baseline and at 1, 3, 6, 9 and 12 months during the course of treatment with HAART. RESULTS: One patient died and another was lost from the follow-up. For the remaining 101 HIV/AIDS patients at the 12th month during the HAART, the plasma viral load (VL) was reduced to (3.2 +/- 0.7) lg copies/ml, the CD4(+) count increased to (168 +/- 51) cells/microl [among which the naive phenotype (CD45RA(+)CD62L(+)) increased to (49 +/- 27) cells/microl and the memory phenotype (CD45RA(-)) increased to (119 +/- 55) cells/microl], and the percentage of CD4(+)CD28(+) cells increased. At the same time, there was a significant reduction of CD8(+) T cell activation. In the 69 patients with the baseline CD4(+) count < 100 cells/microl, 37 had a VL < 50 copies/ml; while in the 34 patients with the baseline CD4(+) count > or = 100 cells/microl, 25 had a VL < 50 copies/ml, the difference between the two groups was statistically significant. The CD4(+) T cell count showed a two-phase increase during HAART and a significant positive correlation was shown between the change of CD4(+) count and plasma VL. Over 12 months of HAART, 10 patients had gastrointestinal side effects, 13 peripheral neuritis, 7 hepatic lesions, 8 hematological side effects, 8 skin rashes, 10 lipodystrophy and 1 renal calculus. CONCLUSIONS: Immune reconstitution as well as the significantly improved clinical outcomes is observed in Chinese advanced AIDS patients after HAART. Side effects are common during HAART and require clinical attention.

[Abnormal changes of CD28 expression on CD4 + T cells in treatment-näive and highly active antiretroviral therapy-treated HIV/AIDS patients].

OBJECTIVE: To study the alteration of the expression of CD28 on CD4 + T cells in HIV/AIDS patients and observe the dynamics of CD28 expression under highly active antiretroviral therapy (HAART). METHODS: The expression of CD28 on CD4 + T cells, CD4 counts, and plasma viral load were measured by flow cytometry and bDNA assays in 278 treatment-naïve HIV/AIDS patients and 56 healthy controls. In addition, the evolution of these parameters was assessed in 59 patients who initiated HAART and were followed for 12 months in regular 3-month visits. RESULTS: The median level of CD28 on CD4 + T cells decreased dramatically in treatment-naïve HIV-positive individuals than in HIV-negative controls (P <0.001). The expression rate of CD28 molecule was positively correlated with CD4 counts (r = 0.484, P < 0.001), and negatively correlated with plasma viral load (r = -0.300, P <0.001). In patients who had received one month of standard HAART, the level of CD28 on CD4 + T cells increased rapidly from 75.0% to 90.0% (P < 0.001). Moreover, there was a negative correlation between the median CD28 expression and the median viral load (r = - 0.829, P = 0.042). CONCLUSIONS: The level of CD28 expression on CD4 + T cells is down-regulated in treatment-naïve HIV/AIDS patients. HAART can successfully restore the lymphocyte subsets of CD4 + CD28 + T cells. The up-regulation of CD28 expression after HAART may be closely correlated with the suppression of the viral replication.

[Clinical characteristics of 143 Chinese HIV/AIDS patients].

OBJECTIVE: To investigate the clinical characteristics of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients in China. METHODS: Totally 143 HIV/AIDS patients who were first diagnosed in Peking Union Medical College Hospital form January 1988 to April 2006 were enrolled in this study. Clinical characteristics were retrospectively analyzed. RESULTS: Among 143 HIV/ AIDS patients, 57 patients had no clinical symptoms and were confirmed by routine examinations; 86 patients had clinical symptoms, including fever (n = 50), weight loss (n = 18), and discomforts involving respiratory system (n = 34), gastrointestinal system (n = 16), and derma and mucosa (n = 17). Opportunistic infections (OIs) such as pneumocystis jiroveci pneumonia (PCP) (n = 27), oropharyngeal candidiasis (n = 16), tuberculosis (n = 15) , and cytomegalovirus (CMV) infection (n = 9) were also observed in patients whose CD4 + T cell counts were less than 200/mm3. Most CMV infection and cryptococcal meningitis occurred in patients whose CD4 + T cell counts were less than 100/mm3. CD4 + T cell count was negatively correlated with plasma viral load (r = -0.420, P = 0.001). CONCLUSIONS: Fever, dyspnea, and weight loss are the most common symptoms in the patients of this study. The respiratory system, gastrointestinal system, derma and mucosa are the most commonly affected areas by OIs, and PCP is the most common OI. The occurrence of OIs corelates with CD4 + T cell count.

Association between Nef-specific CD8 T-cell responses and disease progression in HIV-1 subtype B infection.

BACKGROUND: The correlation between HIV-1 Nef-specific CD8 T-cell responses and markers of HIV-1 disease progression still remains unclear. This study analysed and compared the role of HIV-1 Nef-specific CD8 T-cell responses in patients with different disease status. METHODS: Two groups of patients with HIV-1 subtype B infection were selected according to CD4 count and clinical manifestations: long-term nonprogressors (LTNPs, n = 20) and advanced progressors (APs, CD4 count < 500 cells/microl, n = 34). Nef-specific CD8 T-cell responses were studied by interferon-gamma ELISpot assay against 3 pools of HIV-Nef peptides. RESULTS: Nef-specific CD8 T-cell responses did not correlate with viral load or CD4 count in all patients and no significant differences were found in the magnitude of Nef-specific CD8 T-cell responses between groups LTNPs and APs (670 SFC/10(6) peripheral blood mononuclear cells vs 1107 SFC/10(6) peripheral blood mononuclear cells, P = 0.255). Further comparisons showed that there were also no significant correlations observed in group LTNPs, but Nef-specific CD8 T cells correlated negatively with viral load (r = -0.397, P = 0.020) and positively with CD4 count (r = 0.364, P = 0.034) in group APs. CONCLUSION: These data suggest that different correlation patterns between Nef-specific CD8 T-cell responses and disease progression exist in LTNPs and APs. Although a negative association was observed with concurrent plasma HIV RNA in APs, Nef-specific CD8 T-cell responses might fail to play a protective role in different stages of HIV-1 infection.

[Dynamics of T lymphocyte subsets in HAART treated AIDS patients with successful suppression of HIV replication and different CD4 + T cell restoration].

OBJECTIVE: To study the dynamic changes of T lymphocyte subsets of AIDS patients during more than 24 months of highly active antiretrovirus therapy (HAART) with successful suppression of HIV replication and different CD4 + T cell restoration. METHODS: Totally 45 AIDS patients who had received HAART for more than 24 months were included. During HAART (including DO, M3, M6, M12, M18, and M24), the number of plasma HIV-1 RNA was measured quantitatively using the bDNA assay, and T lymphocyte subsets including CD3 + CD4 + cells, CD3 + CD8 + cells, naive CD4 + cells (CD4 + CD45RA + CD62L +), CD4 + CD28 + cells , and CD8 + CD38 + cells were detected with flow cytometer. RESULTS: Among 45 patients, 24 patients (53.3%) whose plasma viral load decreased to less than 500 copies/ml at M6 and maintained to M24 were classified into three groups according to the CD4 + T cell count increments on M24 (compared with DO): group A (< 100/mm3), group B (100-200/mm3), and group C (> 200/mm3). After the initiation of HAART, T lymphocyte response, including CD4 + T cell counts, naive CD4 + cell counts, percentages of CD4 + CD28 + cells in these patients were improved gradually, while CD8 + CD38 + percentage decreased. The improvement of T lymphocyte response in group C was most remarkable even with highest plasma viral load and lowest CD4 T cell count on DO. Compared with group A and B, group C had significantly better improvement not only in the quantities of CD4 + T cell, but also in the CD28 + expression and naive CD4 + T cell populations. CONCLUSIONS: T lymphocyte response of AIDS patients can be effectively reconstituted by HAART. Different dynamics of CD4 + CD28 + and naive CD4 + populations may considerably contribute to the quantity and cellular function restoration of CD4 + T lymphocyte.

[The correlation of HIV-1 viral load to expression of CD8+ T lymphocyte activators CD38 and HLA-DR].

OBJECTIVE: To investigate the correlation of CD38 and HLA-DR abnormal activating expression on CD8+ T with plasma viral load (VL) and evaluate the possibility of the economical CD38 and HLA-DR test to substitute VL assay in HIV/AIDS patients. METHODS: A multi-point correlation study of the percentage of CD38 and HLA-DR on CD8+ T by flow cytometry with plasma VL by bDNA was performed in 103 HIV/AIDS patients during a 12-month highly active anti-retroviral therapy (HAART). The cutoff values of CD38 and HLA-DR were evaluated with ROC area, sensitivity and specificity for predictive VL < 50 copies/ml, < 500 copies/ml, > 1000 copies/ml and > 10,000 copies/ml respectively. RESULTS: The level of CD38 and HLA-DR on CD8+ T in 103 patients decreased gradually with the reduction of VL during a 12-month HAART. The correlation of CD38 and HLA-DR with VL in the year of HAART was 0.424, 0.376, 0.335, 0.326, 0.297, 0.285 and 0.377, 0.318, 0.333, 0.312, 0.361, 0.358 with significant P value. Moreover, the overall correlation of CD38 and HLA-DR with VL were 0.483 (P < 0.001) and 0.477 (P < 0.001). Depending on optimal ROC, sensitivity and specificity for the substitute method, the cutoffs percentage of CD38 were < 68.5% and < 72.5% for predictive VL < 50 copies/ml and < 500 copies/ml as well as > 39.5% and > 46.5% of HLA-DR cutoff to predict VL > 1000 copies/ml and > 10,000 copies/ml. CONCLUSION: The detection of CD38 and HLA-DR percentage expression on CD8+ T can be available for prediction about HIV VL assay as a substitute method to survey the disease progression and HAART outcome in some resource-limited areas of China.

[Characteristics of immunophenotypic alterations in 263 HIV/AIDS patients].

OBJECTIVE: To explore the characteristics of immunophenotypic alterations of HIV-infected persons/AIDS patients--people living with AIDS (PLWA). METHODS: The clinical data and anti-coagulated blood samples of 263 treatment naive PLWA and 56 healthy controls were collected. Flow cytometry was used to determine the sets of peripheral lymphocytes: B cell, NK cell, CD4(+) T cell including the functional subset (CD28(+)CD4(+) cell), naïve subset (CD4(+)CD45RA(+)CD62L(+) cell), and memory subset (CD4(+)CD45RA(-)cell) of CD4(+) T cell, CD8(+) T cell including the activated subset (CD8(+)CD38(+) cell). Branch DNA (bDNA) assay was used to detect the plasma viral load. RESULTS: The mean CD4(+) T cell count, naïve CD4(+) T cell percentage, and CD28 expression rate in CD4(+) T cells of the PLWA were 205 (348, 63) x 10(6) cells/L, 18.5 (32.0, 6.5)%, and 86.1 (94.0, 68.3)% respectively, all significantly lower than those of the healthy controls [787 (1058, 615) x 10(6) cells/L, 35.4 (45.5, 30.0)%, and 95.7 (97.6, 91.0)% respectively, all P < 0.01]. The percentage of CD38 expression in CD8(+) T cells of the PLWA was 84.3 (92.7, 69.0)%, significantly higher than that of the controls [42.6 (50.6, 36.1)%, P < 0.01]. In the PLWA the CD4(+) T cell count was positively correlated with its CD28 expression (r = 0.480, P < 0.01), and the percentage of CD38 expression in CD8(+) T cells was positively correlated with eh plasma viral load (r = 0.331, P < 0.01). The PLWA were divided into 3 groups according to the CD4(+) T cell count: Group A with the he CD4(+) T cell count < 200 x 10(6) cells/L, Group B with the CD4(+) T cell count of 200 - 350 x 10(6) cells/L, and Group C with the CD4(+) T cell count > 350 x 10(6) cells/L. In comparison with Groups B and C the plasma viral load, activated CD8(+) T cell subset proportion, and percentage of memory CD4(+) T cells of Group A were all significantly higher, and the naive CD4(+) T cell percentage and CD28 expression rate were both significantly lower (all P < 0.01). There were no significant differences in the percentage of memory CD4(+) T cells, CD28 expression, and CD8(+) T cell activated subset proportion between Groups B and C. CONCLUSION: The major immunophenotypic alternations in the PLWA in China include significantly lower counts of CD4(+) T cells and their naive subsets, marked down-regulation of CD28 expression and extremely activated CD8(+) T cells. Distinct features of the immunophenotypic alteration may exist in different disease stages. The CD4(+) T cell count < 200 x 10(6) cells/L may predict more severe immunodeficiency.