Safety Study of Maraviroc's Effect on Human Osteoclasts

NCT01428986 | Completed DMC

• 2 other identifiers: FWA00005823-MVCBone2009UMIN000006266
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

Conditions

HIV Infections; AIDS

Keywords

maraviroc; osteoclasts; Receptors, CCR5; Chemokine CCL5

Outcome Measures

Primary Outcomes (1)

• Evaluation of maraviroc's effect to bone metabolism and bone mineral density

  Follow up HIV infected patients who take maraviroc for their bone mineral density by DEXA and for following blood/urine markers of bone metabolism and chemokine for 72 weeks: * Bone and chemokine markers (DPD, NTX, CTX, TRACP, BAP, osteocalcin, MIP-1alpha, MIP-1beta and RANTES) * Dual-energy X-ray absorptiometry

  78 weeks

Secondary Outcomes (1)

• Duration of the treatment efficacy

  72 weeks

Study Arms (2)

Maraviroc

Those whose take maraviroc as a part of their HIV treatment

Drug: Maraviroc

No maraviroc

Those who do not take maraviroc

Interventions

Maraviroc DRUG

Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks

Also known as: Selzentry, or Celsentri

Maraviroc

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment group: primary care clinic, Non-treatment group: primary care clinic and community sample

You may qualify if:

• Those whose primary care physician acknowledged the necessity of maraviroc treatment due to multi-resistance HIV strain that is confirmed to have CCR5 tropism.
• Those who are willing and able to consent to this study
• years old or older

You may not qualify if:

• Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)
• Others who the principle investigator physician considered to be excluded

Sponsors & Collaborators

• National Center for Global Health and Medicine, Japan: lead

Study Sites (1)

National Center for Global Health and Medicine

Shinjuku, Tokyo, 1628655, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, blood plasma, urine

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Diabetes Mellitus, Insulin-Dependent, 22

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; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kenji Yamamoto, MD PhD

  Vice Director-General of Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 5, 2011
• Study Start: November 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

JP (1)