In short
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.
Key points
- Clinical trials investigating Zidovudine in the provided data are focused on HIV-infected pregnant women and children. Both studies are Phase 3 interventional trials, which means they compare treatment approaches in larger groups of patients. One trial looks at drug levels during pregnancy, after birth, and in infants when relevant. The other trial studies whether treatment can keep HIV suppressed in children aged 2 to under 15 years. Main outcomes include pharmacokinetics, blood levels, and viral rebound.
Trial overview
The available trial data show two Phase 3 studies that include Zidovudine as part of broader HIV treatment research. One study focuses on HIV-infected pregnant women and the other focuses on children with HIV infection aged 2 to under 15 years.
These are interventional studies, which means researchers gave or compared treatments and then measured the results. The trials are not simple observation studies; they are designed to answer specific research questions about treatment use in special patient groups.
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. 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.
The main goal was to describe how these medicines behave in pregnancy when there are no or only limited pregnancy data available. 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.
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. 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.
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. 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.
Zidovudine appears in the list of study medicines as Retrovir, which is one of the antiretroviral drugs included in the trial record. The study aimed to assess maintenance of virological suppression, meaning HIV staying under control, in children who were already being treated.
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. This outcome helps show whether the treatment strategy keeps HIV suppressed over time.
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. Together, these outcomes show two different research goals: understanding how treatment behaves in pregnancy and checking whether HIV remains controlled in children.
- AUC0-tau: total drug exposure over one dosing interval in pregnant women.
- Cmax: highest blood level of the drug after a dose in pregnant women.
- Ctrough: lowest blood level before the next dose, checked to see if it stays effective.
- Half-life: how long the drug stays in the body, measured in women and infants when relevant.
- Viral rebound: return of detectable HIV in children after it had been controlled.
Who can participate
The first study enrolled HIV-infected pregnant women. It also included infant measurements when there was in utero exposure or breastfeeding exposure, if applicable.
The second study enrolled children with HIV infection aged 2 to under 15 years. The trial was designed for children who were already receiving treatment and needed evaluation of maintenance of virological suppression.
Study design and phase
Both trials are listed as Phase 3 and interventional. Phase 3 studies are usually larger studies that help researchers learn more about how well a treatment strategy works in the target population.
NCT00825929 is marked as Completed with an enrollment of 211 participants. NCT04337450 is marked as Authorised with an enrollment of 386 participants.