Studies how HIV medicines move through the body in pregnant women
Measures how antiretroviral medicines act in HIV-infected women during late pregnancy.
Key facts
- Who runs it
- Radboud University Medical Center
- Where
- Brighton and London, United KingdomSee the 6 sitesAlso in 6 other countries, 15 sites
- Trial code
- Registry title
- Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women.
- Status
- Recruiting
- People taking part
- 176 people, planned
- Started
- Feb 2009
- Expected to end
- Dec 2026
- Type of study
- Observational
- Record updated
- 13 January 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion
- Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)
- Inability to understand the nature and extent of the study and the procedures required
- Using oral cabotegravir/rilpivirine
Where in United Kingdom
Also in 6 other countries, 15 sites
- Brighton and Sussex University Hospitals NHS TrustBrighton, United KingdomContact: Yvonne GilleeceTaking people
- C&W Hospital, LondonLondon, United KingdomContact: David Hawkins, MD, PhD (principal investigator)Taking people
- St Mary's Hospital, LondonLondon, United KingdomContact: Graham Taylor, MD, PhD (principal investigator)Taking people
- North Middlesex HospitalLondon, United KingdomContact: David M Burger, PharmD PhDNo longer taking part
- St Thomas HospitalLondon, United KingdomContact: David M Burger, PharmD PhDNo longer taking part
- St. George's Hospital, LondonLondon, United KingdomContact: David M Burger, PharmD PhDNo longer taking part
About the trial
What the trial wants to find out
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 group in the trial
- 1
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)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
- Plain-language title
- Studies how HIV medicines move through the body in pregnant womenGenerated from the registry record. The registry title is the official one.
- Record updated
- 13 January 2025