Phase 1
N=13
The Maraviroc Central Nervous System (CNS) Study
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00982878 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS) — 1.01 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Maraviroc (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS) |
1.01 | — |
| SECONDARY Number of Participants With Adverse Events |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected males or females
- signed informed consent
- plasma HIV RNA 32
- Contraindication to lumbar puncture examination. Such as:
- Existing neurological diseases
- Bleeding disorders
Data sourced from ClinicalTrials.gov (NCT00982878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.