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Maraviroc

Clinical trials investigating Maraviroc are studying its use in people with HIV infection. These trials look at questions such as safety, drug levels in the body, and whether treatment can help reduce the hidden HIV reservoir. The studies include adults, including pregnant women with HIV in one trial.

Table of contents

Clinical trials overview

These studies are investigating Maraviroc as part of clinical research in people with HIV infection.[1] The trial data show two different research goals: one study looks at the hidden HIV reservoir, and the other studies how antiretroviral drugs behave in pregnant women with HIV.[1][2]

The listed trials are interventional, which means the researchers give a treatment and then measure the results.[1][2] The studies are in Phase 2 and Phase 3, showing both early and more advanced clinical research.[1][2]

Phase 2 study on the HIV reservoir

The Phase 2 trial, NCT2024-513366-18-00, is a multicenter, open-label, randomized, controlled study in people with HIV infection.[1] It is authorised and plans to enroll 24 participants.[1]

This study is testing whether giving high doses of antiretroviral drugs can help reduce the latent reservoir, which is the hidden group of HIV-infected cells that can stay in the body even when the virus is controlled.[1] The trial summary says the goal is to evaluate the change in the size of this reservoir after reaching inhibitory tissue concentrations, meaning drug levels in tissues high enough to block HIV activity.[1]

The primary outcome is the size of the latent cell reservoir, measured by total and intact proviral DNA (IPDA).[1] In simple terms, the study is checking how much hidden HIV genetic material remains after treatment.[1]

Phase 3 study in pregnant women with HIV

The second study, NCT00825929, is a Phase 3 trial called PANNA, which studies pharmacokinetics in HIV-infected pregnant women.[2] It is completed and enrolled 211 participants.[2]

Pharmacokinetics means how a drug moves through the body, including how much is in the blood and how long it stays there.[2] In this study, the researchers wanted to describe the pharmacokinetics of antiretroviral agents during the third trimester of pregnancy and after birth, and also in the second trimester for some regimens.[2]

Maraviroc appears in the intervention list as CELSENTRI, showing that this trial included it among many antiretroviral agents being studied.[2] The trial also planned infant pharmacokinetic assessment when exposure occurred, although this was not performed in Germany.[2]

Main outcomes being measured

The Phase 2 trial focuses on latent cell reservoir size, using total and intact proviral DNA as the main measurement.[1] This helps researchers see whether the treatment strategy changes the amount of hidden HIV in the body.[1]

The Phase 3 pregnancy trial measures several drug exposure results, including AUC0-tau, Cmax, Ctrough, tmax, and half-life.[2] It also compares these values during pregnancy and after pregnancy, and checks whether the trough level during pregnancy stays above the minimal effective plasma concentration.[2]

Other outcomes in the pregnancy study include the cord blood to maternal blood ratio at delivery, infant half-life after in utero exposure if applicable, and the breast milk to maternal plasma ratio in breastfeeding cases.[2] These measures help researchers understand how much drug may reach the baby before or after birth.[2]

Who the trials include

The Phase 2 study includes people with HIV infection and is designed for a small group of 24 participants.[1] The trial description does not give more detailed inclusion rules in the source data provided.[1]

The Phase 3 PANNA study includes HIV-infected pregnant women and follows them during pregnancy and after delivery.[2] The source data also mention infant assessment in some cases, which means the study may collect information about babies exposed before birth or through breastfeeding.[2]

What these trials mean for patients

These trials show that Maraviroc is being studied in two different research settings: HIV reservoir reduction and pregnancy pharmacokinetics.[1][2] One study is focused on whether a treatment strategy can lower the amount of hidden HIV, while the other is focused on how antiretroviral treatment behaves in pregnant women and their infants.[1][2]

Together, the trials help answer practical questions about HIV research, including who can join, what is being measured, and whether treatment levels stay in the desired range during pregnancy.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-513366-18-00 Phase 2 HIV infection; latent HIV reservoir Authorised 24
NCT00825929 Phase 3 HIV-infected pregnant women; antiretroviral pharmacokinetics Completed 211

FAQ

  • What are clinical trials of Maraviroc trying to find out? The trials are checking whether Maraviroc can help in HIV research settings, including reducing the latent HIV reservoir and studying how the drug behaves in the body. They also measure blood levels and other markers linked to treatment effect.
  • Who can take part in these trials? The trials shown here include people with HIV infection, and one study focuses on pregnant women with HIV. Each trial has its own rules for who can join.
  • What phases are the Maraviroc trials in? The trials listed are in Phase 2 and Phase 3. Phase 2 studies usually look at early signs of effect, while Phase 3 studies are larger and often compare results in more detail.
  • What conditions are being studied with Maraviroc? The main condition studied is HIV infection. One trial looks at the latent HIV reservoir, and another studies antiretroviral drug levels during pregnancy and after birth.
  • What kinds of results are measured in these trials? The trials measure outcomes such as latent cell reservoir size, total and intact proviral DNA, and drug levels in blood. The pregnancy study also measures cord blood, breast milk, and infant exposure when relevant.

Ongoing Clinical Trials on Maraviroc

  • Study on Reducing HIV Latent Reservoirs Using High Doses of Lamivudine, Maraviroc, and Dolutegravir Sodium for Patients with HIV Infection

    Recruiting

    1 1 1
    Investigated drugs:
    Spain

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

    Not recruiting

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

Glossary

  • HIV infection: A long-term infection caused by the human immunodeficiency virus, which attacks the immune system.
  • Latent reservoir: A hidden group of infected cells where HIV can stay in the body without actively making new virus.
  • Proviral DNA: HIV genetic material that has been inserted into a cell's DNA.
  • Intact proviral DNA (IPDA): A test used to measure HIV DNA that is still complete enough to possibly make new virus.
  • Pharmacokinetics: The study of how a drug 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.
  • Cmax: The highest level of a drug in the blood after it is taken.
  • Ctrough: The lowest level of a drug in the blood before the next dose.
  • tmax: The time it takes for a drug to reach its highest blood level.
  • 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, sometimes tested to see if a drug passed from mother to baby.
  • Breastmilk/maternal plasma ratio: A comparison of the amount of drug in breast milk and in the mother's blood.

References