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Objectives: Women are underrepresented in most HIV clinical trials in Western countries, but their participation remains crucial as the lack of information on sex- and gender-specific effects may hinder the safety and efficacy of antiretroviral treatments. The aim of this study was to identify barriers to and facilitators of women's participation in HIV clinical trials in Switzerland., Methods: We conducted semi-structured interviews among 20 women with HIV to explore factors associated with non-participation in clinical trials. The interviewer presented to participants a clinical trial's description and discussed it with them. Lexicometric analysis on transcribed interviews identified three themes and eight sub-themes related to the pros and cons of participation in HIV clinical trials., Results: Participants evoked mainly decision-making drivers, concerns for women living with HIV and treatment side-effects. They highlighted the need for extensive information provided by trusted healthcare professionals on the research process as central to the decision to enrol in HIV clinical trials. Familial responsibilities were clearly identified as barriers to their participation, but not pregnancy. Additional preoccupations were other health concerns and comorbidities and the consequences of stopping ongoing antiretroviral treatments., Conclusions: To overcome the barriers to the participation of women living with HIV in clinical research in Western countries, healthcare professionals and researchers should increase women's research literacy by involving them in the study design and by tailoring clinical trials to their social roles and health concerns. Trust in professionals is a facilitator of enrolment of women living with HIV that should be maintained., (© 2022 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

This study aims to evaluate the association between dolutegravir (DTG) pharmacokinetic parameters and weight changes in treatment-experienced people with HIV (PWHIV) from the Simpl'HIV study newly switched to a dual DTG-based regimen. We used multivariable linear regressions to evaluate the association between DTG pharmacokinetic parameters at week 48 (derived using an established model) and weight change between week 0 and week 48. We adjusted our model for potential confounders including CD4 nadir, female sex, African origin, age, weight at week 0 and presence of a non-nucleoside reverse transcriptase inhibitor-based regimen before switch to DTG. The analysis included data from 39 PWHIV. An average significant weight gain of 2.4 kg was observed between baseline and week 48. DTG plasma exposure was not significantly associated with weight gain, even after adjusting for potential confounders (P = .9). We found no significant association between DTG pharmacokinetic parameters and weight gain amongst PWHIV newly switched to a DTG-based dual regimen., (© 2021 British Pharmacological Society.)

Background: Recent advances made in cell and gene therapies for cancer suggest that they represent plausible strategies to cure HIV. However, the health risks and constraints associated with these therapies require a deeper understanding of the expectations of such treatments among people living with HIV (PLWH)., Methods: We conducted 15 semistructured in-depth interviews among patients from 2 HIV units in Switzerland. After a conversation about their perceptions of research on HIV therapies, participants were provided with a trial description using a gene-modified cell therapy as a potentially curative approach. They were invited to discuss how they might consider participation in the trial. Content analysis was performed to identify core themes., Results: Participants perceived the trial as burdensome and uncertain. Most were aware that cure was not guaranteed, and 6 of the 15 considered that they would participate. Two main concerns were expressed about potential participation: (1) the impact on the professional life and fear to be stigmatized because of this and (2) the fact that stopping antiretroviral treatment would challenge the balance currently achieved in their lives. The decision to participate would depend on their understanding of the trial, the availability of sufficient information, and the relationship with health care professionals., Conclusion: Involving PLWH in early stages of research would be crucial to improve their understanding of gene-modified cell therapies. It could also help adapt trials to address key factors, including the anticipation of stigma, which may discourage PLWH from participating in treatment research., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)