HIV-infection in pregnant women MedDRA version: 20.0 Level: LLT Classification code 10020175 Term: HIV infection with other conditions System Organ Class: 100000020173
Conditions
Interventions
Trade Name: Intelence
Pharmaceutical Form: Tablet
INN or Proposed INN: etravirine
CAS Number: 269055-15-4
Current Sponsor code: TMC125
Concentration unit: mg milligram(s)
Concentration type: range
Con
Sponsors
Radboud university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 an HAART 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. 7. For raltegravir QD sub-study only: treated with a cART regimen containing raltegravir, or intention of the treating physician to add raltegravir to the cART regimen during pregnancy. Are the trial subjects under 18? yes Number of subjects for this age range: 16 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetics of antiretroviral agents for which no or only limited pharmacokinetic data during pregnancy are available, in the 3rd trimester of pregnant HIV-infected women and at 4-6 weeks post-partum.;Secondary Objective: Determination of pharmacokinetics in the infant in case of post-exposure prophylaxis with one of the agents tested. To describe the safety of the antiretroviral agents during pregnancy and the efficacy in terms of viral load response of the mother and prevention of mother to child transmission.;Primary end point(s): Plasma concentrations of antiretroviral agents will be measured in all available samples by means of a validated HPLC-UV or LC-MS/MS methods. AUC0-12 or 0-24; Cmax; Cmin, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy. Determination of pharmacokinetic parameters in infants if applicable.;Timepoint(s) of evaluation of this end point: second trimester, third trimester of pregnancy and at least 2 weeks post partum | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Cord blood/maternal blood concentration ratio (not mandatory). b) Determination of pharmacokinetic parameters in infants if applicable. c) adverse events and serious adverse events d) HIV-1 RNA viral load at delivery and HIV-infection status of the infants e) progesteron concentrations during pregnancy and postpartum;Timepoint(s) of evaluation of this end point: a) delivery b) week 1, week 3 and between wk 4 and 6 (age of baby). c) entire study d) delivery e) every study visit | — |
Countries
Belgium, Germany, Ireland, Netherlands, Spain, United Kingdom
Contacts
Public ContactAngela Colbers
Radboud university medical center
Outcome results
None listed