Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Radboud University Medical Center176 enrolled

Overview

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.

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; cabotegravir/rilpivirine long acting injectables

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

HIV Infections

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test. 2. Subject is at least 18 years of age at screening. 3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 4. Treated with a cART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation. 5. Subject is pregnant 6. Subject is able to adhere to food intake recommendations, if applicable. Exclusion Criteria: 1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 2. Inability to understand the nature and extent of the study and the procedures required. 3. Presence of grade III/IV anemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL). 4. Using oral cabotegravir/rilpivirine.

Locations (21)

Saint-Pierre University Hospital; Department of Infectious Diseases

Brussels, Belgium

RECRUITING

CHARITÉ Berlin

Berlin, Germany

RECRUITING

University of Bonn

Bonn, Germany

RECRUITING

University of Cologne

Cologne, Germany

RECRUITING

Johann Wolfgang Goethe-Universität

Frankfurt am Main, Germany

RECRUITING

University München

München, Germany

RECRUITING

Mater Hospital and UCD

Dublin, Ireland

RECRUITING

St James's Hospital Dublin

Dublin, Ireland

RECRUITING

IRCSS

Rome, Italy

COMPLETED

AMC

Amsterdam, Netherlands

COMPLETED

...and 11 more locations

Outcomes

Primary Outcomes

Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery

Time frame: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery

Secondary Outcomes

Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study.

Time frame: Week 1, 3 and between 4 and 6

Safety of antiretrovirals during pregnancy

Time frame: GA Week 33 until end of trial

viral load response and prevention of mother to child transmission of the virus

Time frame: GA Week 3 and at delivery

Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.

Overview

Conditions

Eligibility

Locations (21)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts