Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Study Overview
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Brief Summary
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Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state.

Detailed Description
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The following agents will be studied: Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir

Official Title
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Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot. Subject is at least 18 years of age at screening. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. Treated with an HAART regimen containing at least one agent which is mentioned in Appendix 1 of the protocol; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation. Duration of pregnancy not longer than 33 weeks at the day of screening Subject is able to adhere to food intake recommendations. Exclusion Criteria: Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. Inability to understand the nature and extent of the study and the procedures required. Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Treated with one of the antiretroviral agents under study, PK parameters during pregnancy will be compared with PK parameters after pregnancy (within the same woman) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery |  | PK curve in Week 33 of pregnancy and 4-6 weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study. |  | Week 1, 3 and between 4 and 6 | 
| Safety of antiretrovirals during pregnancy |  | GA Week 33 until end of trial | 
| viral load response and prevention of mother to child transmission of the virus |  | GA Week 3 and at delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, pharmacokinetics, pregnancy, antiretrovirals, neonates, treatment experienced