The EuroVacc 02 phase I trial has evaluated the safety and immunogenicity of a prime-boost regimen comprising recombinant DNA and the poxvirus vector NYVAC, both expressing a common immunogen consisting of Env, Gag, Pol, and Nef polypeptide domain from human immunodeficiency virus (HIV)-1 clade C isolate, CN54. 40 volunteers were randomized to receive DNA C or nothing on day 0 and at week 4, followed by NYVAC C at weeks 20 and 24. The primary immunogenicity endpoints were measured at weeks 26 and 28 by the quantification of T cell responses using the interferon γ enzyme-linked immunospot assay. Our results indicate that the DNA C plus NYVAC C vaccine regimen was highly immunogenic, as indicated by the detection of T cell responses in 90% of vaccinees and was superior to responses induced by NYVAC C alone (33% of responders). The vaccine-induced T cell responses were (a) vigorous in the case of the env response (mean 480 spot-forming units/106 mononuclear cells at weeks 26/28), (b) polyfunctional for both CD4 and CD8 T cell responses, (c) broad (the average number of epitopes was 4.2 per responder), and (d) durable (T cell responses were present in 70% of vaccinees at week 72). The vaccine-induced T cell responses were strongest and most frequently directed against Env (91% of vaccines), but smaller responses against Gag-Pol-Nef were also observed in 48% of vaccinees. These results support the development of the poxvirus platform in the HIV vaccine field and the further clinical development of the DNA C plus NYVAC C vaccine regimen.

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Despite higher discontinuation rates among women, men had an increased risk of virological rebound and slightly poorer CD4(+) T-cell count responses. Identifying the reasons underlying treatment discontinuation/switch may help optimize treatment strategies for both genders.

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Summary: This guideline provides evidence-based guidance on the content of safer sex advice and the provision of brief behaviour change interventions deliverable in genitourinary (GU) medicine clinics. Much of the advice is applicable to other healthcare settings including general practice and clinics providing HIV care. Advice on condom use and effectiveness, oral sex and other sexual practices, testing for sexually transmitted infections (STI) and partner reduction is provided. Advice specific to the transmission of HIV infection including seroadaptive behaviours and negotiated safety is also included. An accompanying review of the evidence supporting the guideline with a complete reference list is available online. A patient information leaflet based on the advice statements developed is also available through the BASHH website.Keywords: sexually transmitted diseases, safe sex, risk reduction behaviour, condoms, HIV infections SCOPE AND PURPOSEThe objective of this document is to provide guidance for practitioners in Level 3 genitourinary (GU) medicine services (Tier 5 in Scotland) on safer sex advice provided in sexually transmitted infection (STI) and HIV management consultations. The guideline consists of: † Recommendations on the format and delivery of brief behaviour change interventions deliverable in GU medicine clinics; † Recommendations on the content of safer sex advice given to individuals at continued risk of STI; † Additional advice to be provided for those living with HIV, or from groups with higher rates of HIV incidence.Much of the guidance is applicable in other sexual health and general practice settings, including HIV care services. The evidence base for the recommendations is summarized in an accompanying online document. Issues relating to implementation of behaviour change interventions in clinics, such as designing service structures and care pathways or the competencies required in different multidisciplinary staff groups, will be addressed in British Psychological Society (BPS) Good Practice Guidelines.1 Safer sex advice and individual behaviour change interventions provided within clinics are elements of a combination prevention approach to STIs and HIV 2,3 that may also include group and community-based behavioural interventions, structural and social changes and for HIV, biomedical interventions including postexposure prophylaxis for HIV following sexual exposure (PEPSE), pre-exposure prophylaxis (PrEP) 4 and the early initiation of antiretroviral therapy (ART). IDENTIFYING CANDIDATES FOR SAFER SEX ADVICE AND OTHER PREVENTION INTERVENTIONSNo systematic reviews, meta-analyses or original studies describing methods to systematically target potential candidates for interventions were found. The selection of patients for advice and behavioural interventions should be based on demographic group and individual history taking to identify recognised risk factors. 5,6 Guidance on eliciting risk factors is detailed in the BPS guidelines.1 Those at increased risk may include: † Adolescents...

This study reflects the experience of patients in routine care. Selection of protease gene mutations by lopinavir/ritonavir occurred at a much higher rate than in clinical trials. The mutations observed showed only partial overlap with those previously identified by structural chemistry models, serial cell culture passage and genotype-phenotype analyses. There remained a low degree of predicted cross-resistance to other widely used PIs.