Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

NCT00987948 | Completed Phase 2 Results

• 1 other identifier: H005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV Infections

Keywords

HIV; dementia; High HIV DNA within CD14+ PBMCs; treatment experienced

Outcome Measures

Primary Outcomes (1)

• 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

  Week 24 minus baseline

  Baseline to 24 weeks

Secondary Outcomes (1)

• Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores

  Baseline to 24 Weeks

Study Arms (1)

Maraviroc

EXPERIMENTAL

Drug: maraviroc (Selzentry)

Interventions

maraviroc (Selzentry) DRUG

dosage varies with other medications being taken; will follow package insert guidelines

Maraviroc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 50 copies/ml for a period of 1 year."
• Willingness for both males and females of childbearing potential to utilize 2 effective contraception methods (2 separate forms, one of which must be an effective barrier method), be non-heterosexually active or have a an exclusive vasectomized partner from screening throughout the duration of the study treatment and for 30 days following the last dose of study drugs.
• Age \>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) \<5 x ULN
• Creatinine \<1.5 x ULN
• Lipase \<2.0 x ULN
• Estimated creatinine clearance \> 60 mL/min.
• HIV DNA within peripheral blood mononuclear cells \> 100 copies/mL
• Not currently receiving Maraviroc as part of ARV regimen

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hawaii: lead
• Pfizer: collaborator

Study Sites (1)

Hawaii Center for AIDS

Honolulu, Hawaii, 96816, United States

Location

MeSH Terms

Conditions

HIV Infections; Dementia

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Cecilia M Shikuma
• Organization: Hawaii Center for AIDS, University of Hawaii

shikuma@hawaii.edu

8086921328

Study Officials

• Cecilia M Shikuma, M.D.

  University of Hawaii at Manoa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 1, 2009
• Study Start: January 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: August 1, 2013
• Last Updated: March 22, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-02

Locations

US (1)