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Atazanavir

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.

Table of Contents

Trial overview

The trial data show one study of Atazanavir in HIV-infected pregnant women.[1] The study was titled Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA).[1]

This was a completed interventional study, which means the researchers gave treatment and measured outcomes instead of only observing people.[1] The study enrolled 211 participants and was listed as Phase 3.[1]

Who was studied

The main target group was HIV-infected pregnant women.[1] The study summary says the main focus was the third trimester of pregnancy and the post-partum period, which is the time after delivery.[1]

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.[1] Post-exposure prophylaxis means medicine given after a possible exposure to reduce the chance of infection.[1]

What the trial measured

The primary outcome was pharmacokinetics, which is how the body handles a drug over time.[1] The study measured AUC0-tau, Cmax, Ctrough, tmax, and half-life in pregnant women.[1]

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.[1] The study also looked at whether Ctrough in pregnancy stayed above the minimal effective plasma concentration, meaning the lowest level thought to still work.[1]

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.[1] These measures help show how much drug reaches the baby before and after birth.[1]

Study design and phase

The study was a Phase 3 trial.[1] 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.[1]

The study was completed and had 211 enrolled participants.[1] 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.[1]

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.[1]

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?[1] This matters because pregnancy can change how the body processes medicine.[1]

By comparing pregnancy and post-partum drug levels, the study aimed to show whether the dose exposure stayed within the expected range.[1] The infant and breastmilk measurements were added to better understand exposure around delivery and during breastfeeding.[1]

Trial ID Phase Condition studied Status Enrollment
NCT00825929 Phase 3 HIV-infected pregnant women Completed 211

FAQ

  • Who can take part in Atazanavir clinical trials? The trial data shown here focus on HIV-infected pregnant women. Some parts of the study also look at infants after exposure before birth or through breastfeeding.
  • What is being studied in these trials? The main goal is to measure pharmacokinetics, which means how the body absorbs, uses, and removes a drug. The study also checks drug levels in the mother, cord blood, breastmilk, and sometimes the infant.
  • What phase is the Atazanavir study? The trial listed for Atazanavir is a Phase 3 study. Phase 3 trials usually test a treatment in a larger group and collect more detailed information.
  • What condition is being studied? The condition listed is HIV infection in pregnant women. The study is focused on pregnancy and the time after delivery.
  • What outcomes are measured in the trial? The trial measures levels such as AUC, Cmax, Ctrough, tmax, and half-life. In simple terms, these show how much drug is in the body, the highest level reached, the lowest level before the next dose, when the highest level happens, and how long the drug stays in the body.

Ongoing Clinical Trials on Atazanavir

  • Study on the Effects of Abacavir Sulfate and Etravirine in Pregnant Women with HIV

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Ireland The Netherlands Spain

Glossary

  • Pharmacokinetics: The study of how a drug moves through the body, including how it is absorbed, how high the level gets, and how long it stays there.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group of people.
  • HIV-infected: A person living with HIV, the virus that can weaken the immune system.
  • Pregnant women: Women who are carrying a baby during pregnancy.
  • Post-partum: The time after a baby is born.
  • AUC0-tau: A measure of total drug exposure over one dosing interval.
  • Cmax: The highest level of the drug in the blood.
  • Ctrough: The lowest level of the drug in the blood before the next dose.
  • tmax: The time when the drug reaches its highest level in the blood.
  • Half-life: The time it takes for the amount of a drug in the body to drop by half.
  • Cord blood: Blood from the umbilical cord at birth, which can show whether a drug reached the baby before delivery.
  • Breastmilk/maternal plasma ratio: A comparison of drug levels in breastmilk and the mother's blood.

References