Study of Pharmacokinetics in HIV-infected Women
Women represent an increasing proportion of HIV cases globally and in Canada, yet are underrepresented in clinic trials. It is therefore critical to conduct this study on antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV drug levels in women and their relation to adverse events (AEs).
The hypothesis for this study is three-fold:
- that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our female population as compared to the mean drug levels in the historical HIV population (which is primarily men)
- that ARV drug levels, particularly Cmin, are associated with body weight in women
- that higher ARV drug levels, particularly Cmax, are associated with higher frequency and severity of AEs.
The objectives of this study are as follows:
- To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as compared to the mean drug levels in the historical general population (which is primarily men).
- To determine the association between PI and NNRTI minimum concentration (Cmin) and body weight in our female population.
- To determine the association between maximum concentration (Cmax) and the frequency and severity of AEs as measured by the proportion of patients with grade 2 or higher laboratory or clinical AEs and the Symptom Index Score in women.
- To determine the association between ARV drug levels and age, race, height, body mass index, adherence, hormonal levels and therapy, menstruation history, duration of HIV infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4 count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other medications.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression on Combination Antiretroviral Therapy|
Blood samples will be drawn before and after antiretroviral drugs are taken for visits 1-3.
|Study Start Date:||February 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Drug: antiretroviral treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433979
|Canada, British Columbia|
|Children and Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Downtown Infectious Diseases Clinic|
|Vancouver, British Columbia, Canada, V6Z 2C7|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Canada, Nova Scotia|
|Capital District Health Authority|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Hamilton Health Sciences - McMaster University|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Ottawa Health Research Institute|
|Ottawa, Ontario, Canada, K1Y 4E9|
|University of Ottawa Health Services|
|Ottawa, Ontario, Canada, K1N 6N5|
|University Health Network - Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2N2|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Canadian Immunodeficiency Research Collaborative|
|Toronto, Ontario, Canada, M5B 1L6|
|Windsor Regional Hospital HIV Care Program|
|Windsor, Ontario, Canada, N8W 1E3|
|Centre de recherche du Centre hospitalier de l'Universite de Montreal (CHUM)|
|Montreal, Quebec, Canada, H2W 1T7|
|Montreal Chest Institute|
|Montreal, Quebec, Canada, H2X 2P4|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Mona R Loutfy, MD FRCPC MPH||Women's College Hospital|