Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stichting Radboud universitair medisch centrum
- Enrollment
- 163
- Locations
- 16
- Primary Endpoint
- AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this study is 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 post-partum. And in the 2nd trimester for raltegravir once-daily regimen and dolutegravir regimen. In addition, the pharmacokinetics will be determined in the infant as well in case of post-exposure prophylaxis with one of the agents tested (not performed in Germany).
Investigators
Angela Colbers
Scientific
Stichting Radboud universitair medisch centrum
Eligibility Criteria
Inclusion Criteria
- •HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
- •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 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.
- •Subject is pregnant.
- •Subject is able to adhere to food intake recommendations, if applicable.
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).
- •Using oral cabotegravir/rilpivirine.
Outcomes
Primary Outcomes
AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
AUC0-tau; Cmax; Ctrough, tmax, thalf for pregnant women. Comparison between these parameters during pregnancy and the parameters after pregnancy using mixed model analysis .
Ctrough in pregnancy should be above the minimal effective plasma concentration.
Ctrough in pregnancy should be above the minimal effective plasma concentration.
Cord blood/maternal blood concentration ratio at delivery.
Cord blood/maternal blood concentration ratio at delivery.
Determination of half life in infants after in utero exposure if applicable (washout half life).
Determination of half life in infants after in utero exposure if applicable (washout half life).
Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.
Breastmilk/maternal plasma ratio in case of breastfeeding and exposure in child if breastfeeding.
Secondary Outcomes
- Description of maternal viral suppression during pregnancy and postpartum.
- Description of infection status of infants at birth.
- Description of SAEs and AEs reported during pregnancy and postpartum.