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.

Women receiving efavirenz-based antiretroviral therapy plus a contraceptive implant had significantly lower levonorgestrel pharmacokinetics than women not receiving antiretroviral therapy. An unexpected high pregnancy rate (3/20, 15%) occurred in the efavirenz group, highlighting the clinical significance of this interaction.

Objective: To examine determinants of contraceptive use, desired future childbearing, and sterilization regret among HIV-positive women.Methods: 118 HIV-positive women, age 18-46, receiving care at a University HIV Clinic completed a survey on their reproductive history in 2004. We reviewed their medical records for contraception, antiretroviral medications and HIV/AIDS disease markers. We performed descriptive analysis of population characteristics and logistic regression to assess predictors of their desire to have future children.Results: Subjects had a median age of 37, had been diagnosed with HIV for a mean of 9.2 years and 55% had AIDS. Most (68%) subjects were currently monogamous and 29% were abstinent. Forty-seven percent had been sterilized and of those who were sexually active but not sterilized, 90% were using reversible contraception. One-third of subjects desired future childbearing, including 12% of those who had been previously sterilized. In a multivariate analysis, predictors of desire for future childbearing were: younger age, not being on HIV medication, higher current CD4 cell count and having a relationship duration of less than 2 years. Conclusion:HIV-positive women have reproductive patterns similar to HIV-negative women, with most having borne children and many wanting children in the future. A substantial proportion has been sterilized and express sterilization regret. Potent antiretroviral therapy has greatly improved the outlook for HIV-infected women, even those with an AIDS diagnosis. Many HIV-positive women want to have children and would benefit from preconception counseling and counseling about reversible methods of contraception.

We conducted an open-label, steady-state pharmacokinetic (PK) study of drug interactions among HIV-infected women treated with depo-medroxyprogesterone acetate (DMPA) while on nucleoside analogues plus nelfinavir (N=21), efavirenz (N=17), or nevirapine (N=16); or nucleosides only or no antiretroviral therapy as a control group (N=16). PK parameters were estimated using non-compartmental analysis, with between-group comparisons of medroxyprogesterone acetate (MPA) PKs and within-subject comparisons of ARV PKs before and 4 weeks after DMPA dosing. Plasma progesterone levels were measured at baseline and at 2, 4, 6, 8, 10, and 12 weeks after DMPA dosing. There were no significant changes in MPA area under the concentration curve, peak or trough concentrations, or apparent clearance in the nelfinavir, efavirenz, or nevirapine groups compared to the control group. Minor changes in nelfinavir and nevirapine drug exposure were seen after DMPA, but were not considered clinically significant. Suppression of ovulation was maintained.