Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study.

Background: Antiretroviral therapy (ART) management is challenging for individuals in resource-limited settings presenting for third-line treatment because of complex resistance patterns, partly due to reduced access to viral load monitoring. We aimed to evaluate use of newer antiretroviral drugs and contemporary management approaches, including population-based sequencing, to select appropriate antiretrovirals, plasma viral load monitoring, and interventions to improve adherence in individuals presenting with second-line viral failure.

Methods: A5288 was a phase 4, third-line ART strategy study done at 19 urban sites in ten countries that enrolled adult participants with confirmed plasma HIV-1 RNA (viral load) of 1000 copies per mL or more after more than 24 weeks of protease inhibitor-based second-line ART.

Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1.

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure).

Engagement in care among youth living with parenterally-acquired HIV infection in Romania.

Transition from adolescent to adult care can be challenging for youth living with HIV. We conducted a cohort study of youth born between 1985 and 1993 and infected with HIV parenterally, followed by the same medical team from age 15 years or first clinic visit until age 25 years or 30 November 2016. A longitudinal continuum-of-care was constructed, categorizing individuals' status for each month of follow-up as: engaged in care (EIC); not in care (NIC: no clinic visits within past year); lost-to-follow-up (LTFU: NIC and did not return to clinic); or died.

Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial.

Background: Current treatment for HIV-infected individuals with renal failure on haemodialysis frequently requires complex regimens with multiple pills. A daily single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is approved in Europe, the USA, and in other regions for use in HIV-1-infected individuals with mild-to-moderate chronic kidney disease (creatinine clearance 30-69 mL/min). We aimed to assess the safety, efficacy, and pharmacokinetics of this regimen in HIV-infected adults with end-stage renal disease on chronic haemodialysis.

Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.

In 2 double-blind phase 3 trials, 1733 antiretroviral-naive adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs 80.

Euroguidelines in Central and Eastern Europe (ECEE) conference and the Warsaw Declaration - a comprehensive meeting report.

Objectives: The objective of this paper is to summarize the outcomes of the Euroguidelines in Central and Eastern Europe (ECEE) conference held in Warsaw in February 2016. The main aim of this conference was to facilitate a discussion on European AIDS Clinical Society (EACS) guidelines implementation across the region and neighbouring countries and to present the current obstacles in benchmarking HIV care in Europe.

Methods: During a 2-day meeting, there were country-based presentations using a predefined template so as to make the data comparable and focus the discussion.

Relation of Childhood Sexual Abuse, Intimate Partner Violence, and Depression to Risk Factors for HIV Among Black Men Who Have Sex With Men in 6 US Cities.

Objectives: We assessed the relation of childhood sexual abuse (CSA), intimate partner violence (IPV), and depression to HIV sexual risk behaviors among Black men who have sex with men (MSM).

Methods: Participants were 1522 Black MSM recruited from 6 US cities between July 2009 and December 2011. Univariate and multivariable logistic regression models were used.

Which adults in the Paris metropolitan area have never been tested for HIV? A 2010 multilevel, cross-sectional, population-based study.

Background: Despite the widespread offer of free HIV testing in France, the proportion of people who have never been tested remains high. The objective of this study was to identify, in men and women separately, the various factors independently associated with no lifetime HIV testing.

Methods: We used multilevel logistic regression models on data from the SIRS cohort, which included 3006 French-speaking adults as a representative sample of the adult population in the Paris metropolitan area in 2010.

Biomedical HIV Prevention Including Pre-exposure Prophylaxis and Opiate Agonist Therapy for Women Who Inject Drugs: State of Research and Future Directions.

Women who inject drugs (WWID) are at higher risk of HIV compared with their male counterparts as a result of multiple factors, including biological, behavioral, and sociostructural factors, yet comparatively little effort has been invested in testing and delivering prevention methods that directly target this group. In this article, we discuss the need for expanded prevention interventions for WWID, focusing on 2 safe, effective, and approved, yet underutilized biomedical prevention methods: opiate agonist therapy (OAT) and oral pre-exposure prophylaxis (PrEP). Although both interventions are well researched, they have not been well examined in the context of gender.

Predictors of HVTN 503 MRK-AD5 HIV-1 gag/pol/nef vaccine induced immune responses.

Background: Phambili, the Merck (MRK)-Adenovirus Type 5 (Ad5) HIV-1 gag/pol/nef subtype B vaccine study, conducted in South Africa, suspended enrollment and vaccination when companion study, Step, was found non-efficacious. Although the vaccine did not prevent HIV-1 infection or lower viral-load setpoint, immune responses recognized clades B and C HIV-1 subtypes. We investigated predictors of the vaccine-induced antigen-specific immune responses.

Recombinant adenovirus type 5 HIV gag/pol/nef vaccine in South Africa: unblinded, long-term follow-up of the phase 2b HVTN 503/Phambili study.

Background: The HVTN 503/Phambili study, which assessed the efficacy of the Merck Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine in South Africa, was stopped when futility criteria in the Step study (assessing the same vaccine in the Americas, Caribbean, and Australia) were met. Here we report long-term follow-up data.

Methods: HVTN 503/Phambili was a double-blind, placebo-controlled, randomised trial that recruited HIV-1 uninfected, sexually active adults aged 18-35 years from five sites in South Africa.

Ecological factors influencing HIV sexual risk and resilience among young people in rural Kenya: implications for prevention.

Most new HIV infections in Kenya occur among young people. The purpose of this study was to understand ecological factors that influence HIV-related sexual risk and resilience among young people in rural Kenya and to elicit their ideas for HIV prevention interventions. Nine focus groups (N = 199) were conducted with both female (55%) and male (45%) participants (ages 14-24 years) living in rural communities in Kenya.

Improvement in lipid profiles in antiretroviral-experienced HIV-positive patients with hyperlipidemia after a switch to unboosted atazanavir.

Objective: The primary objective was to compare the change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 12 between patients receiving an atazanavir-containing regimen and those receiving comparator protease inhibitor (PI) regimens.

Design: AI424-067 was a 48-week, open-label, randomized, prospective study of 246 patients on PI-based regimens with hyperlipidemia [fasting LDL cholesterol >130 mg/dL (>3.4 mmol/L)] and with HIV RNA <50 copies per milliliter.

Long-Term suppression of HIV infection: benefits and limitations of current treatment options.

HIV type 1, a causative agent of AIDS, is a source of worldwide morbidity and mortality. There are an estimated 1 million people in North America currently living with HIV infection, and more than 40,000 new cases occur annually. Before the advent of highly active antiretroviral therapy (HAART), the mortality rate of HIV infection was nearly 100%, and life expectancy was short.

Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study.

Background: Studies of the effect of highly active antiretroviral therapy (HAART) on the risk of HIV-1-associated tuberculosis have had variable results. We set out to determine the effect of HAART on the risk of tuberculosis in South Africa.

Methods: We compared the risk of tuberculosis in 264 patients who received HAART in phase III clinical trials and a prospective cohort of 770 non-HAART patients who were attending Somerset Hospital adult HIV clinic, University of Cape Town, between 1992 and 2001.

Salvage treatment in HIV disease.

The need for salvage treatment is related to the imperfection of current antiretroviral therapy. Sequential therapy with suboptimally suppressive regimens results in a need for this intervention. The aim of salvage treatment is as yet uncertain; virological suppression; immunoenhancement or stability or avoidance of clinical disease.

Highly active antiretroviral treatment in HIV infection: benefits for neuropsychological function.

Objectives: To determine whether highly active antiretroviral therapy (HAART) is associated with reduced HIV-associated neuropsychological impairment.

Design: Cross-sectional analysis in a natural history study of adaptation to HIV/AIDS.

Method: A sample of 130 homo-/bisexual men with HIV/AIDS (mean age, 41 years; 42% non-white) were evaluated with a neuropsychological battery assessing attention, concentration, psychomotor speed, learning, memory and executive function.

Substance use disorders in gay/bisexual men with HIV and AIDS.

The authors conducted a longitudinal study of psychological adaptation to AIDS in subjects with and without lifetime and current substance use disorders (SUD), in a cohort of HIV+ gay/bisexual subjects. A sample of HIV+ gay/bisexual men (n = 183) and an HIV- comparison group (n = 84) were assessed for SUD, depression, and anxiety disorders. Among HIV+ men, combined lifetime (42%) but not current (11.

Does physical improvement reduce depressive symptoms in HIV-infected medical inpatients?

The Beck Depression Inventory, Karnofsky Scale of Physical Performance, and a visual-analogue scale to assess subjective distress were administered to 32 HIV-infected medical inpatients shortly after admission and prior to discharge. Twenty-eight percent of subjects had severe depressive symptoms on admission. Most of these subjects remained in the severe range of depressive symptoms at discharge, despite physical improvement comparable to subjects with lower levels of depressive symptoms.

Self-disclosure of HIV infection to sexual partners after repeated counseling.

This study, with the objective of examining voluntary self-disclosure of HIV infection after repeated counseling, was conducted in a private setting, and designed to operate in conjunction with HIV testing. Counseling was provided at entry, and then at 3 months, 6 months, and every six months thereafter. The study was conducted among 129 HIV-positive adults; the primary risk factor was history of: males having sex with males (n = 104); injection drug use (n = 19); or heterosexual contact (n = 6).