Study of Pharmacokinetics in HIV-infected Women

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

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) 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:

1. 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)

2. that ARV drug levels, particularly Cmin, are associated with body weight in women

3. that higher ARV drug levels, particularly Cmax, are associated with higher frequency and severity of AEs.

The objectives of this study are as follows:

Primary objectives:

1. 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).

2. To determine the association between PI and NNRTI minimum concentration (Cmin) and body weight in our female population.

Secondary objectives

1. 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.

2. 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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's College Hospital
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Anti-Retroviral Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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