エイズと臨床研究のジャーナル

Background: We report 96- and 144-week follow-up data from VERxVE, demonstrating that nevirapine (NVP) extended release (XR) 400 mg once daily was non-inferior to NVP immediate release (IR) 200 mg twice daily, each administered on a backbone of emtricitabine/tenofovir. Methods: VERxVE was a double-blind, double-dummy, non-inferiority study in adults with screening viral load (VL) >1000 copies/mL and CD4+ cell count <400 cells/mm3 (males) or <250 cells/mm3 (females). Randomisation was stratified by baseline VL (copies/mL) ≤ 100,000 or >100,000. The primary endpoint was confirmed virologic response (<50 copies/mL) at week 48. Cochran’s statistic incorporating baseline VL strata tested non-inferiority of XR efficacy versus IR. Secondary endpoints included 144-week sustained virologic response and safety. Results: In all, 1011 patients were randomised and treated with NVP: 736 (XR n=378; IR n= 358) completed 144 weeks. Virologic response was 63.6% for NVP XR and 58.5% for NVP IR (adjusted difference of 4.8% [95% confidence interval –1.1% to 10.8%] favouring NVP XR). No significant differences were seen in changes in CD4+ T-cell counts from baseline, virologic failures or total discontinuation rates between treatment arms, regardless of demographic or baseline characteristics. Conclusions: NVP XR demonstrated non-inferior virologic efficacy to NVP IR in treatment-naïve HIV-infected patients and was well tolerated out to week 144, with a safety profile similar to NVP IR.

Background: In India, there is a lack of awareness and inadequate knowledge about use of Highly Active Antiretroviral Therapy (HAART) due to social stigma leading to intentional non-adherence among Human Immunodeficiency Virus (HIV) infected patients thus, Educational Intervention (EI) must be sought. Need for the study: There is a need for an EI program for HIV-infected patients for improving adherence to Antiretroviral Therapy (ART). Aim: The aim of the study was to evaluate the impact of an EI on use of HAART and its effect on adherence behavior in Intervention Care Group (ICG) in comparison with Standard Care Group (SCG) in HIV infected patients. Methods: A prospective, randomized, controlled study was conducted at Kasturba hospital Manipal from August 2009 to May 2012 in HIV infected patients. The baseline response for Knowledge, Attitude, Belief, and Practice (KABP) questionnaire was assessed. Block randomization was used to assign the patients to the SCG and ICG. In ICG group, patients are educated every 4 weeks for a total of 16 weeks with Patient Information Leaflet (PIL), adherence counseling and awareness to Adverse Drug Reactions (ADRs) to ART by a clinical pharmacist. In ISG group, patients are given standard care for ART treatment by a clinician. Post KABP response was documented in both groups at 16th week and adherence rate was measured. Repeated-measures Analysis of Variance (RANOVA) was used for the comparison of pre and post total KABP responses between ICG and SCG. Results: A total of 256 HIV positive patients were enrolled. Out of which 16 patients were excluded because they were on traditional medicines and 240 HIV-infected patients with HAART were finally included in the study, of whom 120 (89 [74.2%] men, 31[25.8%] women) were randomly assigned to the ICG and 120 (99 [82.5%] men, 21[17.5%] women) to the SCG. Pre and post KABP responses significantly increased with mean ± standard deviation (SD) (p<0.001) and greater than 95% of adherence (p<0.001) was reported in ICG after EI in comparison with SCG. Conclusion: The EI program on use of HAART in this study changed their intentional non-adherence behavior, negative beliefs and social stigma.

Objective: To determine the incidence, risk factors and prognosis for incident tuberculosis during the follow-up of HIV-infected patients in Guadeloupe. Methods: We conducted a retrospective cohort study using STATA version IC 10.0 (College Station, Texas, USA). Results: A single failure Cox proportional hazards model showed that patients with B CDC category (HR=4.50; 95%CI=1.50-13.60; P=0.007) and patients with C CDC category (HR=138.30; 95%CI=62.80-304.90; P=0.000) were at an increased risk of tuberculosis, whereas patients with low median CD4 count at enrolment ( HR=0.50; 95%CI=0.30- 0.84; P=0.009) and patients treated by ART ( HR=0.45; 95%CI=0.34-0.62; P=0.000) were associated with a low risk of tuberculosis. Conclusion: Our data showed a high incidence of tuberculosis and no socio-economic factors related to tuberculosis among HIV-infected patients. These findings help to effectively guide public health interventions.

The Human Immune deficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS) pandemic have had a profound effect on the health and social life of people in Nigeria. This study was aimed at assessing the perception level of voluntary counseling/ testing and knowledge/ awareness of HIV/AIDS among the adult population in Ugep town of Cross-River State of Nigeria. One hundred and sixty (160) male and female residents of Ugep metropolis between the ages of 17 and 60 were surveyed. A 20-item structured questionnaire was administered to participants. Analysis of the responses showed that one hundred and twenty four (77.5%) understands what HIV/ AIDS is while 98.1% are aware of the routes of transmission. Sixty five percent and 98.8% respectively have a good knowledge of the signs/symptoms and prevention of the disease. Only 15.6% of the respondents are aware of the availability of medical treatment for HIV/AIDS. Sixty seven (47.5%) respondents affirmed that they will stigmatize people living with HIV/AIDS. One hundred and forty nine (93.1%) were aware of Voluntary Testing and Counselling (VCT) of which ninety five (59.4%) had undergone one. A minority group of the respondents 63(39.4%) believed that life would still be worth living if they are sero positive. Eighty eight (61.2%) said they cannot disclose their HIV status to anyone while sixty five (40.6%) believed that VCT can bring about an HIV-free society. Sixty five (40.6%) respondents have never gone for VCT for several reasons. Alarmingly, 20 respondents said they would commit suicide if they were to be sero-positive while 5 would spread the virus to others. The level of knowledge and awareness of HIV/AIDS is yet to achieve desired goals and impact. There is need for urgent intervention by the relevant bodies to educate and enlighten the populace.

Although there has been growing interest in the provision of integrated reproductive health and HIV services in sub-Saharan Africa in recent decades, there is limited evidence on effectiveness of linking family planning clients who test HIV-positive to comprehensive care centers with respect to such outcomes as uptake of care and support services as well as initiation of clients to antiretroviral therapy for those eligible. This paper examined the acceptability and effectiveness of linking HIV-positive family planning (FP) clients to treatment and care services among health care providers in Kenya. Data are from a pre- and post-intervention study without a comparison group. Intervention activities included modifying the referral system, reviewing and updating training materials and job aids, training service providers on the updated tools, and conducting support supervision. Data collection involved facility assessment, provider interviews, and record reviews. Analysis entails descriptive statistics including frequencies, percentages and scores with significant tests of means and proportions to determine if there were any significant differences between baseline and endline. The results show that although most facilities were not adequately prepared in terms of infrastructure to support linking HIV-positive family planning clients to treatment and care services, there was significant improvement in provider acceptance of referral practices after than before the interventions. For example, the proportion of providers who used a directory for referral rose from 8% at baseline to 58% at endline (p<0.01) while the proportion of providers who discussed referral of HIV-positive FP clients improved from 71% at baseline to 96% at the endline (p<0.05). In addition, whereas there was initially no referral of HIVpositive FP clients to comprehensive care centers (CCCs), most of the HIV-positive FP clients received at CCCs (93%) were from within the Maternal-Child-Health (MCH)/FP unit of the same facility during the intervention period indicating that the referral system was effective.

HIV Co-infection complicates the natural history, clinical course, therapy and management for HIV. The individuals affected represent a treatment challenge fraught with controversies associated with drug resistance, cross-resistance, hepatotoxicity and suboptimal response. This is a descriptive review of co-infection in HIV positive individuals. Studies have shown that HIV co-infection accelerates the natural course of hepatotropic viruses and increased risk of liver cirrhosis, hepatocellular carcinoma, and decompensated liver disease in co-infected individuals. Studies have equally shown increased risk of progression to acquired immunodeficiency syndrome AIDS and AIDS-related death among HIV/HCV co-infected persons and HCV may affect the management of HIV infection, increasing the incidence of liver toxicity associated with antiretroviral regimens. Dual HBV/ HCV co-infection tend to have more severe liver cirrhosis and hepatitis decompensation, and a higher incidence of hepatocellular carcinoma. HIV is a strong risk factor for TB. High prevalence rates are significantly correlated with high TB incidence rates. Tuberculosis equally accelerates the progression of disease in HIV.

Co-infection with HIV is a growing public health problem worldwide. There is need for enlightenment and further researches to highlight the importance of public health follow-up and reduction measures for HIV co-infected individuals in order to prevent subsequent infections.

Background: Candida albicans is a commensal fungus of the mucosa in humans that may become an opportunistic pathogen causing recurrent infections in immunocompromised hosts. In individuals with HIV/AIDS, Histatin-5 levels are significantly reduced, causing oropharyngeal candidiasis to become a pathological process. Clinical and in vitro resistance to azoles is common whether by selection or acquisition of Candida-resistant strains. In 2008, the Clinical and Laboratory Standards Institute (CLSI) defined the cutoff point for active agents against the isolates of Candida species. The objective of this study was to determine the frequency of fungal isolates of C. albicans through VITEK II system and their susceptibility pattern in patients with HIV/AIDS and oropharyngeal candidiasis treated at the Hospital for Infectious Diseases in Mexico City.

Methods: From June 2011-December 2012, there were 96 patients with HIV/AIDS and oropharyngeal candidiasis who were included in the study. Oral and esophageal specimens were directly examined to identify fungal structures. Cultures and sensitivity testing were done with the Vitek II method. Descriptive statistics and bivariate analysis were carried out.

Results: Of 96 patients, 87 had C. albicans oral isolates identified and 73 esophageal isolates. Non-albicans Candida (NAC) was identified in three and ten patients (oral and esophageal) respectively, and Cryptococcus neoformans was isolated in both sites. Sensitivity of C. albicans to fluconazole was demonstrated in 87/90 strains.

Conclusions: The fungal pathogen isolated was C. albicans followed by C. glabrata and C. parapsilopsis. C. albicans was identified through VITEK II in 90% of cases susceptible to fluconazole.

The interaction of Tuberculosis and HIV has deadly consequences around the world, especially in sub Saharan Africa. Diagnosis is challenging particularly in childhood in countries with limited resources. This review focuses on the epidemiology of co-infection, clinical presentation and management of affected patients