Status:
COMPLETED
Study of Pharmacokinetics in HIV-infected Women
Lead Sponsor:
Women's College Hospital
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
HIV Infections
Eligibility:
FEMALE
18-65 years
Brief Summary
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) pharmaco...
Detailed Description
Predictors of antiretroviral pharmacokinetics in HIV-infected women with virologic suppression on combination antiretroviral therapy Background Women in Canada constitute the fastest growing populat...
Eligibility Criteria
Inclusion
- Patient must be HIV infected
- Patient must be 18 years old or older
- Patient must be a biologic woman
- Patient must be taking her first combination ARV regimen that includes a PI or an NNRTI for the past three months with no changes in any agent of the combination in that period (first combination ARV regimen is defined as a regimen started when the patient was ARV-naïve; however switches are allowed as long as the switches are not for virologic failure)
- Patient must be taking either a PI or an NNRTI but not both
- If taking a PI, patient must be taking only one PI excluding low dose ritonavir used as boosting
- Patient must have a viral load \< 50 copies/mL on two occasions at least 1 month apart including a value within three months before the baseline visit
- Patient has to have signed and dated a full informed consent
Exclusion
- Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
- Patient who is pregnant or breast-feeding
- Patient with a malignancy receiving systemic chemotherapy
- Patient with end stage organ disease
- Patient with other significant non-HIV underlying disease that might impinge upon disease progression or death
- Patient who is not taking standard dosing of a PI or NNRTI as listed in Appendix G
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00433979
Start Date
February 1 2007
End Date
February 1 2009
Last Update
July 30 2012
Active Locations (15)
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1
Children and Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada, V6Z 2C7
4
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7