• To assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir (darunavir/r) and/or etravirine during the second and third trimesters of gestation, as well as postpartum [ Time Frame: During the second and third trimesters of gestation, as well as postpartum ] [ Designated as safety issue: No ]
  

• Changes in anti-viral activity and safety and tolerability of darunavir/r and/or etravirine-based antiretroviral regimens during gestation and postpartum; compare darunavir/r and/or etravirine concentrations between serum and cord blood;pregnancy outcome [ Time Frame: During gestation and postpartum. ] [ Designated as safety issue: No ]
  

There are many biological changes that occur during pregnancy, some of which may affect the way HIV medications are absorbed, distributed and removed within the body. Some medications have been used for HIV treatment during pregnancy, but little is known about how pregnancy affects the class of drugs being looked at in this study. To participate in this study, patients must be receiving 600mg of TMC114 (darunavir) taken with 100mg TMC114r (ritonavir) twice daily and/or 200mg of TMC125 (etravirine) twice daily, plus additional antiretroviral drugs needed to construct an active antiretroviral regimen. Darunavir and ritonavir, and/or etravirine will be supplied to study participants. Darunivir and ritonavir are human immunodeficiency virus (HIV) protease inhibitors (PIs); etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV. Twelve-hour blood sampling will be done for each patient at each of three study visits: Visit 4 (2nd trimester), Visit 5 (3rd trimester), and Visit 8 (6-12 weeks postpartum). Eight blood draws will be taken during each visit: One prior to intake of study medication, and one for each of seven post-dose sampling time-points (hours 1, 2, 3, 4, 6, 9 and 12).

The study is designed primarily to look at the pharmacokinetics of darunavir/ritonavir (darunavir/r) and/or etravirine during the second and third trimesters of gestation, as well as postpartum. Pharmacokinetics measures how the body absorbs, distributes and excretes medication. The study will also look for any changes in anti-viral activity during pregnancy, and the postpartum period. It will observe any safety and tolerability of the medications used by the mother, and will measure the level of darunavir/r and/or etravirine in the newborn's cord blood at the time of delivery; outcomes for both mother and child will be assessed as well. During the treatment period, patients will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Up to thirty-six (36) HIV positive pregnant women will participate in this study. Study enrollment will be closed once 12 evaluable patients taking darunavir/ritonavir, and 12 evaluable patients taking etravirine have been enrolled. The study will be conducted at approximately 14 research centers in the United States and 1 in Puerto Rico. In order to participate, patients must be pregnant for 13-24 weeks. The primary purpose (or outcome) of the study is to assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir (darunavir/r) and/or etravirine during the second and third trimesters of gestation, as well as postpartum. Information collected in this study may be analyzed after either 12 patients on darunavir/r or 12 patients on etravirine have completed their last visit. A final analysis will be completed after all 24 patients (12 taking darunavir/ritonavir (darunavir/r) and 12 taking etravirine) have completed their last visit. Darunavir: One 600 mg or two 300 mg tablets taken twice daily by mouth (two or four tablets a day total). Ritonavir: 100mg capsules taken twice daily by mouth (two capsules a day total), together with darunavir. Etravirine: Two 100 mg tablets taken twice daily by mouth (four tablets a day total). Study medication will be given from the baseline visit (second pregnancy trimester) until Visit 8 (up to 12 weeks after delivery).