Predictors of Virologic Failure in HIV/AIDS Patients Treated with Highly Active Antiretroviral Therapy in Brasília, Brazil During 2002–2008

Little data exists concerning the efficacy of the antiretroviral therapy in the Federal District in Brazil, therefore in order to improve HIV/AIDS patients’ therapy and to pinpoint hot spots in the treatment, this research work was conducted. Of 139 HIV/AIDS patients submitted to the highly active antiretroviral therapy, 12.2% failed virologically. The significant associated factors related to unresponsiveness to the lentiviral treatment were: patients’ place of origin (OR = 3.28; IC95% = 1.0–9.73; P = 0.032) and Mycobacterium tuberculosis infection (RR = 2.90; IC95% = 1.19–7.02; P = 0.019). In the logistic regression analysis, the remaining variables in the model were: patients’ birthplace (OR = 3.28; IC95% = 1.10–9.73; P = 0.032) and tuberculosis comorbidity (OR = 3.82; IC95% = 1.19–12.22; P = 0.024). The patients enrolled in this survey had an 88.0% therapeutic success rate for the maximum period of one year of treatment, predicting that T CD4+ low values and elevated viral loads at pretreatment should be particularly considered in tuberculosis coinfection, besides the availability of new antiretroviral drugs displaying optimal activity both in viral suppression and immunological reconstitution

Rates of HIV testing and diagnosis in South Africa: successes and challenges

Background: UNAIDS aims for 90% of HIV-positive individuals to be diagnosed by 2020, but few attempts have been made in developing countries to estimate the fraction of the HIV-positive population that has been diagnosed. Methods: To estimate the rate of HIV diagnosis in South Africa, reported numbers of HIV tests performed in the South African public and private health sectors were aggregated, and estimates of HIV prevalence in individuals tested for HIV were combined. The data were integrated into a mathematical model of the South African HIV epidemic, which was additionally calibrated to estimates of the fraction of the population ever tested for HIV, as reported in three national household surveys. Results: The fraction of HIV-positive adults who were undiagnosed declined from more than 80% in the early 2000s to 23.7% [95% confidence interval (95% CI) 23.1 - 24.3] in 2012. The undiagnosed proportion in 2012 was substantially higher in men (31.9%, 95% CI 29.7 - 34.3) than in women (19.0%, 95% CI 17.9 - 19.9). Conclusion: South Africa has made significant progress in expanding access to HIV testing, and at current testing rates, the target of 90% of HIV-positive adults diagnosed by 2020 is likely to be reached. However, uptake is relatively low in men and older adults.

Antiretroviral Therapy, Sexually Transmitted Infections, and Adverse Pregnancy Outcomes in South Africa

We read with interest the article by Theron et al. on their post hoc analysis of the Promoting Maternal and Infant Survival Everywhere (PROMISE) 1077BF/1077FF trials. They found an increased incidence of low birth-weight (LBW) infants (<2500 g) and adverse pregnancy outcomes in women who conceived while on antiretroviral therapy (ART) compared with those who restarted ART after pregnancy was diagnosed. Their study adds an important data point to the limited, and sometimes contradictory, evidence regarding safety of ART in pregnancy and its relationship with adverse pregnancy outcomes.The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH); the President’s Emergency Plan for AIDS Relief through the US Agency for International Development; the NIH and Fogarty International Center; the National Institute of Mental Health; the National Institute for Allergy and Infectious Diseases.https://academic.oup.com/cidam2022Medical Microbiolog

Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation

Background. HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years), and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is attributable in part to high adolescent infection rates and supports the urgent need for more efficacious prevention strategies. In particular, an even partially effective HIV vaccine, given prior to sexual debut, is predicted to significantly curb adolescent infection rates. While adolescents have indicated willingness to participate in HIV vaccine trials, there are concerns around safety, uptake, adherence, and ethical and logistic issues.Objectives. To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA).Method. A simulated HIV vaccine trial was conducted in adolescents aged 12 - 17 years across five SA research sites, using the already licensed Merck human papillomavirus vaccine Gardasil as a proxy for an HIV vaccine. Adolescents were recruited at community venues and, following a vaccine discussion group, invited to participate in the trial. Consent for trial enrolment was obtained from a parent or legal guardian, and participants aged 16 - 17 years were eligible only if sexually active. Typical vaccine trial procedures were applied during the five study visits, including the administration of vaccination injections at study visits 2, 3 and 4.Results. The median age of participants was 14 years (interquartile range 13 - 15), with 81% between the ages of 12 and 15 years at enrolment. Overall, 98% of screened participants opted to receive the vaccine, 588 participants enrolled, and 524 (89%) attended the final visit.Conclusions. This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual-risk eligibility criteria and the requirement for parental/guardian consent, which was probably a barrier to the enrolment of high-risk older adolescents. Further debate around appropriate consent approaches for such adolescents in HIV prevention studies is required

Background morbidity in HIV vaccine trial participants from various geographic regions as assessed by unsolicited adverse events.

Background: Recently, more clinical trials are being conducted in Africa and Asia, therefore, background morbidity in the respective populations is of interest. Between 2000 and 2007, the International AIDS Vaccine Initiative sponsored 19 Phase 1 or 2A preventive HIV vaccine trials in the US, Europe, Sub-Saharan Africa and India, enrolling 900 healthy HIV-1 uninfected volunteers.   Objective To assess background morbidity as reflected by unsolicited adverse events (AEs), unrelated to study vaccine, reported in clinical trials from four continents. Methods All but three clinical trials were double-blind, randomized, and placebo-controlled. Study procedures and data collection methods were standardized. The frequency and severity of AEs reported during the first year of the trials were analyzed. To avoid confounding by vaccine-related events, solicited reactogenicity and other AEs occurring within 28 d after any vaccination were excluded. Results In total, 2134 AEs were reported by 76% of all participants; 73% of all events were mild. The rate of AEs did not differ between placebo and vaccine recipients. Overall, the percentage of participants with any AE was higher in Africa (83%) compared with Europe (71%), US (74%) and India (65%), while the percentage of participants with AEs of moderate or greater severity was similar in all regions except India. In all regions, the most frequently reported AEs were infectious diseases, followed by gastrointestinal disorders. Conclusions Despite some regional differences, in these healthy participants selected for low risk of HIV infection, background morbidity posed no obstacle to clinical trial conduct and interpretation. Data from controlled clinical trials of preventive interventions can offer valuable insights into the health of the eligible population