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Zidovudine

Clinical trials investigating Zidovudine are studying HIV-infected pregnant women and children. These studies look at how the treatment is handled in pregnancy and whether it helps keep HIV under control in children. They focus on measures such as drug levels, virological suppression, and infant exposure.

Table of Contents

Trial overview

The available trial data show two Phase 3 studies that include Zidovudine as part of broader HIV treatment research.[1][2] One study focuses on HIV-infected pregnant women and the other focuses on children with HIV infection aged 2 to under 15 years.[1][2]

These are interventional studies, which means researchers gave or compared treatments and then measured the results.[1][2] The trials are not simple observation studies; they are designed to answer specific research questions about treatment use in special patient groups.[1][2]

Pregnancy study in HIV-infected women

NCT00825929, called PANNA, studied the pharmacokinetics of antiretroviral agents in HIV-infected pregnant women, including during the third trimester and after delivery.[1] The brief summary also says that some medicines were studied in the second trimester for specific regimens, and that infant pharmacokinetics were measured when post-exposure prophylaxis was used.[1]

The main goal was to describe how these medicines behave in pregnancy when there are no or only limited pregnancy data available.[1] The primary outcomes included AUC0-tau, Cmax, Ctrough, tmax, and thalf for the pregnant women, plus comparison of these values during pregnancy and after pregnancy.[1]

Other outcomes in this study included the cord blood to maternal blood concentration ratio at delivery, the half-life in infants after in utero exposure if applicable, and the breastmilk to maternal plasma ratio if breastfeeding occurred.[1] The study also checked whether the trough level in pregnancy stayed above the minimal effective plasma concentration, which means the lowest level thought to still work.[1]

Child study on virological suppression

NCT04337450 studied whether DTG/3TC fixed-dose formulations were non-inferior to DTG plus 2 NRTIs in children with HIV infection aged 2 to under 15 years.[2] Non-inferior means the new approach was being tested to see if it was not worse than the comparison treatment by more than an allowed amount.[2]

Zidovudine appears in the list of study medicines as Retrovir, which is one of the antiretroviral drugs included in the trial record.[2] The study aimed to assess maintenance of virological suppression, meaning HIV staying under control, in children who were already being treated.[2]

The primary outcome was the proportion of children with confirmed viral rebound by week 96, defined as the first of two consecutive HIV-1 RNA results of 50 copies/mL or higher.[2] This outcome helps show whether the treatment strategy keeps HIV suppressed over time.[2]

Main outcomes measured

The pregnancy study focused on drug exposure and movement in the body, while the child study focused on control of HIV over time.[1][2] Together, these outcomes show two different research goals: understanding how treatment behaves in pregnancy and checking whether HIV remains controlled in children.[1][2]

  • AUC0-tau: total drug exposure over one dosing interval in pregnant women.[1]
  • Cmax: highest blood level of the drug after a dose in pregnant women.[1]
  • Ctrough: lowest blood level before the next dose, checked to see if it stays effective.[1]
  • Half-life: how long the drug stays in the body, measured in women and infants when relevant.[1]
  • Viral rebound: return of detectable HIV in children after it had been controlled.[2]

Who can participate

The first study enrolled HIV-infected pregnant women.[1] It also included infant measurements when there was in utero exposure or breastfeeding exposure, if applicable.[1]

The second study enrolled children with HIV infection aged 2 to under 15 years.[2] The trial was designed for children who were already receiving treatment and needed evaluation of maintenance of virological suppression.[2]

Study design and phase

Both trials are listed as Phase 3 and interventional.[1][2] Phase 3 studies are usually larger studies that help researchers learn more about how well a treatment strategy works in the target population.[1][2]

NCT00825929 is marked as Completed with an enrollment of 211 participants.[1] NCT04337450 is marked as Authorised with an enrollment of 386 participants.[2]

Trial ID Phase Condition studied Status Enrollment
NCT00825929 Phase 3 HIV-infected pregnant women Completed 211
NCT04337450 Phase 3 HIV-infected children aged 2 to <15 years Authorised 386

FAQ

  • What are the Zidovudine trials studying? The trial data focus on HIV-infected people in special groups, mainly pregnant women and children. The studies measure drug levels in the body and how well treatment keeps HIV suppressed.
  • Who can take part in these trials? One trial includes HIV-infected pregnant women, and another includes children with HIV infection aged 2 to under 15 years. Each trial has its own rules for who can join.
  • What phase are the Zidovudine-related trials? The trials listed are both Phase 3 studies. Phase 3 means the treatment is being studied in larger groups to better understand how well it works and how it behaves in the body.
  • What outcomes are being measured? The studies measure pharmacokinetics, which means how the drug moves through the body, including blood levels and half-life. In children, the main outcome is viral rebound, which means HIV levels rise again after being controlled.
  • Are these trials only about Zidovudine? No. The trial records include Zidovudine as part of broader HIV treatment studies, alongside other antiretroviral medicines. The focus is on treatment strategies and drug behavior in specific patient groups.

Ongoing Clinical Trials on Zidovudine

  • Study on Dolutegravir and Lamivudine for Maintaining Viral Control in Children with HIV Aged 2 to Under 15 Years

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • 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

  • HIV-infected: A person who has HIV, the virus that attacks the immune system.
  • Pregnant women: Women who are carrying a baby. In these trials, researchers study how treatment behaves during pregnancy.
  • Children with HIV infection: Young patients who have HIV. One trial studies children aged 2 to under 15 years.
  • Phase 3: A later stage of clinical research in larger groups of people. It helps show how well a treatment works and how safe or practical it is to use.
  • Interventional study: A trial where researchers give a treatment or compare treatments and then measure the results.
  • Pharmacokinetics: How a medicine moves through the body, including how much gets into the blood and how long it stays there.
  • AUC0-tau: A measure of total drug exposure over one dosing interval. It helps show how much medicine is in the body over time.
  • Cmax: The highest level of a medicine found in the blood after a dose.
  • Ctrough: The lowest level of a medicine in the blood before the next dose.
  • Half-life: The time it takes for the amount of a medicine in the body to drop by half.
  • Virological suppression: When HIV is reduced to very low levels, so it is harder to detect and control.
  • Viral rebound: When HIV levels rise again after being lowered by treatment.

References