No abstract

Background Non-nucleoside reverse transcriptase (NNRTI) inhibitor-based antiretroviral therapy is not suitable for all treatment-naïve HIV-infected persons. Objective Perform a rigorous evaluation of three NNRTI-sparing initial antiretroviral regimens to demonstrate equivalence for virologic efficacy and tolerability. Design Phase-III, 1:1:1 randomized, open label, >96 week study. Setting Fifty-seven sites in United States and Puerto Rico. Patients Treatment naïve, ≥18 years, HIV-1 RNA >1000 copies/mL, no nucleoside reverse transcriptase or protease inhibitor resistance. Intervention Atazanavir 300 mg with ritonavir 100 mg, daily; or raltegravir 400 mg twice daily; or darunavir 800 mg with ritonavir 100 mg, daily; plus emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg daily. Measurements Virologic failure defined as confirmed HIV-1 RNA >1000 copies/mL between 16 and 24 weeks, or >200 copies/mL at or after 24 weeks; tolerability failure defined as discontinuation of atazanavir, raltegravir or darunavir for toxicity. A secondary endpoint was a combination of virologic efficacy and tolerability. Results Among 1,809 participants all pairwise comparisons of incidence of virologic failure over 96-weeks demonstrated equivalence within ±10%. Raltegravir and ritonavir-boosted darunavir were equivalent for tolerability, whereas ritonavir-boosted atazanavir resulted in a 12.7% and a 9.2% higher incidence of tolerability discontinuation than raltegravir and ritonavir-boosted darunavir respectively, primarily due to hyperbilirubinemia. For combined virologic efficacy and tolerability ritonavir-boosted darunavir was superior to ritonavir-boosted atazanavir, and raltegravir was superior to both protease inhibitors. Antiretroviral resistance at time of virologic failure was rare but more likely with raltegravir. Limitations Open label; ritonavir not provided Conclusions Over 2 years all three regimens attain high and equivalent rates of virologic control. Regimens containing raltegravir or ritonavir-boosted darunavir have superior tolerability compared to the ritonavir-boosted atazanavir regimen. Primary Funding Source National Institute of Allergy and Infectious Diseases

Women with HIV/AIDS report substantially poorer HRQoL than men with HIV/AIDS in several HRQoL domains. However, changes in domain scores over time and in response to treatment do not differ significantly by gender, implying that changes in domain scores may be better HRQoL outcomes to compare between HIV-infected men and women in clinical trials than mean domain scores.

Background-Antiretrovirals (ARVs) are recommended for maternal health and to reduce HIV-1 mother-to-child transmission, but suboptimal adherence can counteract its benefits.

Observational studies have examined the prevalence and impact of internalized stigma among African American women living with HIV, but there are no intervention studies investigating stigma reduction strategies in this population. Based on qualitative data previously collected, we adapted the International Center for Research on Women's HIV Stigma Toolkit for a domestic population of African American women to be consistent with Corrigan's principles of strategic stigma change. We implemented the intervention, led by an African American woman living with HIV, as a workshop across two afternoons. The participants discussed issues ''triggered'' by videos produced specifically for this purpose, learned coping mechanisms from each other, and practiced them in role plays with each other. We pilot tested the intervention with two groups of women (total N = 24), measuring change in internalized stigma with the Stigma Scale for Chronic Illness before and after workshop participation. Sixty-two percent of the participants self-reported acquiring HIV through heterosexual sexual contact, 17% through intravenous drug use, 4% in utero, and 13% did not know the route of transmission. The intervention was feasible, enthusiastically accepted by the women, and led to decreased stigma from the start of the workshop to the end ( p = 0.05) and 1 week after ( p = 0.07) the last session of workshop. Findings suggest the intervention warrants further investigation.