In short
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.
Key points
- Clinical trials investigating Maraviroc are focused on HIV infection. One Phase 2 study is testing whether high doses of antiretroviral drugs can reduce the hidden HIV reservoir. Another Phase 3 study in pregnant women with HIV is measuring how antiretroviral drugs behave in the body during pregnancy and after birth. The trials include small and larger patient groups, with 24 people in the Phase 2 study and 211 in the pregnancy study. Main outcomes include reservoir size, drug blood levels, and exposure in cord blood, breast milk, and infants when applicable.
Clinical trials overview
These studies are investigating Maraviroc as part of clinical research in people with HIV infection. 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.
The listed trials are interventional, which means the researchers give a treatment and then measure the results. The studies are in Phase 2 and Phase 3, showing both early and more advanced clinical research.
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. It is authorised and plans to enroll 24 participants.
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. 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.
The primary outcome is the size of the latent cell reservoir, measured by total and intact proviral DNA (IPDA). In simple terms, the study is checking how much hidden HIV genetic material remains after treatment.
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. It is completed and enrolled 211 participants.
Pharmacokinetics means how a drug moves through the body, including how much is in the blood and how long it stays there. 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.
Maraviroc appears in the intervention list as CELSENTRI, showing that this trial included it among many antiretroviral agents being studied. The trial also planned infant pharmacokinetic assessment when exposure occurred, although this was not performed in Germany.
Main outcomes being measured
The Phase 2 trial focuses on latent cell reservoir size, using total and intact proviral DNA as the main measurement. This helps researchers see whether the treatment strategy changes the amount of hidden HIV in the body.
The Phase 3 pregnancy trial measures several drug exposure results, including AUC0-tau, Cmax, Ctrough, tmax, and half-life. 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.
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. These measures help researchers understand how much drug may reach the baby before or after birth.
Who the trials include
The Phase 2 study includes people with HIV infection and is designed for a small group of 24 participants. The trial description does not give more detailed inclusion rules in the source data provided.
The Phase 3 PANNA study includes HIV-infected pregnant women and follows them during pregnancy and after delivery. 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.
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. 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.
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.