A Phase 1 interventional study of Maraviroc in HIV Infections, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-04.
Sponsored by Imperial College London · Phase 1, Interventional, and Treatment
The purpose of this study is to describe the Central Nervous System exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.
15 HIV-1 infected subjects currently receiving stable antiretroviral therapy will be recruited. At study entry, within 14 days of screening procedures, subjects will commence maraviroc dosed at 150 mg twice daily. For the rest of study period antiretroviral therapy will comprise:
Subjects will attend for regular clinic visits during study treatment phase.
On day 15, subjects will attend the unit in the morning prior to usual dosing time. Blood with be drawn to assess plasma maraviroc concentration pre dose and pre lumbar puncture. A lumbar puncture will be performed under standard aseptic techniques to asses CSF maraviroc concentration and routine CSF parameters.
On completion of this study visit, subjects will cease maraviroc, continue on their usual antiretroviral regimen and attend for a follow up visit 10 days later.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 13 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
currently receiving a stable antiretroviral regimen comprising of:
Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 30 days following last dose of study drug:
Exclusion Criteria:
Contraindication to lumbar puncture examination. Such as:
Drug: Maraviroc
150mg twice daily
CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)
To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state. It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS). Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist
Time frame: 15 days
Number of Participants With Adverse Events
To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy
Time frame: 15 days
| Milestone | Maraviroc |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state. It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS). Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist
| ratio | Maraviroc |
|---|---|
| CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS) | 1.01 (0.57 to 1.61) |
To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy
| Participants | Maraviroc |
|---|---|
| Number of Participants With Adverse Events | 0 |
Collected over 15 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maraviroc | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Maraviroc |
|---|---|
| Mean | 42 ± 7.9 |
| Sex: Female, Male(Participants) | Maraviroc |
|---|---|
| Female | 3 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Maraviroc |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 4 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Maraviroc |
|---|---|
| United Kingdom | 12 |
| Years since HIV diagnosis(years) | Maraviroc |
|---|---|
| Mean | 11 ± 4.6 |
| Baseline CD4 cell count(cells/ul) | Maraviroc |
|---|---|
| Mean | 503 ± 199 |
| BMI(kg/m^2) | Maraviroc |
|---|---|
| Mean | 28 ± 3.5 |
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Imperial College London