Study of Pharmacokinetics in HIV-infected Women

The patient population will consist of 80 HIV-infected women (who are on their first cART regimen containing either a PI or an NNRTI for at least three months and who have evidence of full virologic suppression (HIV RNA VL < 50 copies/mL) on at least two occasions at least one month apart. The first cART regimen can include ARV switches as long as these switches are not due to virologic failure. The patient population is being limited to women who have full virologic suppression to avoid inclusion of women with difficulty with drug adherence.

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