CTN 233: Pharmacokinetics of antiretroviral therapy (ARV) in HIV-positive women

About The Study

The purpose of this study is to examine the ARV pharmacokinetics (how the treatments are processed in the body) of Cmin and Cmax (mean drug levels) in HIV-positive women, as well as determining if mean drug levels are higher compared to men (from historical results). The study will also investigate whether mean drug levels of ARVs are associated with body weight, and higher frequency and severity of adverse events such as nausea, diarrhea, liver toxicity and lipodystrophy (fat wasting or accumulation) in women.

Researchers will be seeking women who are:

Taking their first combination ARV regimen that includes a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor for at least three months (switches for non-virologic failure reasons acceptable)

AND

Have evidence of viral load of less than 50 copies/mL on at least two occasions at least one month apart.

This is an observational study that requires three visits over three weeks. Participants will not be required to take any special drugs as this study involves only questionnaires and the collection and testing of blood.

This is a Canadian study that will recruit 80 participants at 15 sites across Canada.

Study Approach

Studies have found that ARV drug levels are higher in women and that these higher drug levels are associated with increased toxicity in this population. Because it is unknown whether higher drug levels are related to hormonal influences, drug metabolism, adherence, fat distribution, body size or other factors, researchers are interested in measuring drug levels in HIV-infected women who are taking anti-HIV drugs. This study will determine the predictors of high drug levels and will assess the relationship between drug levels and adverse events in women.