In short
Clinical trials are investigating Atazanavir as part of studies in HIV-infected pregnant women. These trials mainly look at how the drug behaves in the body during pregnancy and after birth, and whether drug levels stay effective. The research also includes infant exposure in some cases.
Key points
- Clinical trials investigating Atazanavir are focused on HIV-infected pregnant women. The main study is a Phase 3 trial that looks at pharmacokinetics, which means how the drug moves through the body during pregnancy and after delivery. The trial also measures drug levels in cord blood, breastmilk, and sometimes infants. One completed study enrolled 211 participants. The research is designed to understand whether drug exposure stays adequate during pregnancy and after birth.
Trial overview
The trial data show one study of Atazanavir in HIV-infected pregnant women. The study was titled Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA).
This was a completed interventional study, which means the researchers gave treatment and measured outcomes instead of only observing people. The study enrolled 211 participants and was listed as Phase 3.
Who was studied
The main target group was HIV-infected pregnant women. The study summary says the main focus was the third trimester of pregnancy and the post-partum period, which is the time after delivery.
The study summary also says that pharmacokinetics were checked in the infant if there was post-exposure prophylaxis with one of the tested agents, although this was not done in Germany. Post-exposure prophylaxis means medicine given after a possible exposure to reduce the chance of infection.
What the trial measured
The primary outcome was pharmacokinetics, which is how the body handles a drug over time. The study measured AUC0-tau, Cmax, Ctrough, tmax, and half-life in pregnant women.
AUC0-tau shows the total drug exposure over a dosing interval, while Cmax is the highest blood level and Ctrough is the lowest level before the next dose. The study also looked at whether Ctrough in pregnancy stayed above the minimal effective plasma concentration, meaning the lowest level thought to still work.
Other measures included the cord blood/maternal blood concentration ratio at delivery, the half-life in infants after exposure in the womb, and the breastmilk/maternal plasma ratio if breastfeeding occurred. These measures help show how much drug reaches the baby before and after birth.
Study design and phase
The study was a Phase 3 trial. Phase 3 studies are usually larger studies that help researchers understand how well a treatment performs in a defined group and gather more detailed information about its use.
The study was completed and had 211 enrolled participants. The brief summary says the trial aimed to describe pharmacokinetics for antiretroviral agents with little or no pregnancy data, especially in the third trimester and after delivery.
The summary also notes that pharmacokinetics were studied in the second trimester for raltegravir once-daily and dolutegravir regimens, but the Atazanavir information in the source is part of the broader PANNA study context.
What the results were meant to show
The trial was designed to answer a practical question: does Atazanavir reach and maintain blood levels that are important during pregnancy and after birth? This matters because pregnancy can change how the body processes medicine.
By comparing pregnancy and post-partum drug levels, the study aimed to show whether the dose exposure stayed within the expected range. The infant and breastmilk measurements were added to better understand exposure around delivery and during breastfeeding.