Phase 2 N=15 Treatment

Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00987948 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Mar 2017

Primary outcome: Primary: Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells — 0.58 Log-10 copies/10^6 cells

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: maraviroc (Selzentry) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Hawaii
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells	0.58	—
SECONDARY Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores	0.57	—

Summary

High levels of HIV infection within blood monocyte/macrophages (a type of white cells in the bloodstream) increases risk of dementia in HIV-infected individuals. Maraviroc (Selzentry) is a HIV medication that works by blocking the entry of HIV in cells including monocytes/macrophages that use a receptor called CCR5. The study hypothesis is that the addition of Maraviroc to a HIV antiretroviral regimen in HIV-infected individuals with high levels of HIV-infected monocyte/macrophages will lead to a decrease in the levels of infected monocyte/macrophages and to decrease in brain inflammation as studied by magnetic resonance spectroscopy (MRS, a form of MRI study).

Eligibility Criteria

Inclusion Criteria

HIV-1 infection as documented by ELISA and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA by RT-PCR or bDNA at any time prior to study entry.
Receipt of ARV medication uninterrupted for > 1 year leading up to the screening period with demonstrated HIV RNA 18 years.
Ability and willingness to provide written informed consent
The following laboratory parameters documented within 30 days prior to study entry:
Hemoglobin >8.0
Absolute neutrophil count >500
Platelet count >40,000
AST (SGOT) and ALT (SGPT) 60 mL/min.
HIV DNA within peripheral blood mononuclear cells > 100 copies/mL
Not currently receiving Maraviroc as part of ARV regimen

Exclusion Criteria

Past or present HIV opportunistic infection of the brain, learning disability, head injury with prolonged loss of consciousness or cognitive sequelae, or other non-HIV risk factor that may impact cognitive performance.
Any factor that precludes MRI scan including presence of metal or exposure to metal work (e.g., metal grinder/worker) and claustrophobia
History of seizure disorder
History of myocardial infarction, angina, congestive heart failure, peripheral vascular disease, angioplasty or cardiac surgery
Current malignancy or history of past malignancies excluding basal cell CA
Any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
Any vaccination within 30 days of study entry.
Requirement for acute therapy for other AIDS-defining illness or other serious medical illnesses (in the opinion of the site investigator) within 14 days prior to study entry.
Other chronic illnesses including diabetes, autoimmune diseases, and endocrinopathies, except subjects on stable physiologic replacement therapy for low testosterone or thyroid levels
Known hypersensitivity to Maraviroc
Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Current active substance or alcohol dependence
Pregnancy or breast-feeding, intent to become pregnant during the course of the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00987948). 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.