Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial.

ABSTRACT:

Background

Women account for an increasing proportion of patients with HIV-1 but remain underrepresented in antiretroviral clinical trials.

Objective

To evaluate sex-based differences in efficacy and adverse events in treatment-experienced, HIV-positive women and men receiving darunavir-ritonavir therapy over 48 weeks.

Design

Multicenter, open-label, phase 3b study designed to enroll a high proportion of women, with sample size determined on the basis of a noninferiority design with a maximum allowable difference of 15% in virologic response favoring men. (ClinicalTrials.gov registration number: NCT00381303)

Setting

65 sites in the United States, Puerto Rico, and Canada.

Patients

287 women and 142 men.

Intervention

Patients received darunavir-rito

SUBMITTER: Currier J 

PROVIDER: S-EPMC3056066 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature