Safety Study of Maraviroc's Effect on Human Osteoclasts

HIV Infections Clinical Trial

— MVC-Bone  

Official title:

Safety Study of Maraviroc's Effect on Human Osteoclasts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428986
• Other study ID #: FWA00005823-MVCBone2009
• Secondary ID: UMIN000006266
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: September 24, 2014
• Start date: November 2009
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: National Center for Global Health and Medicine, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Description:

An observational study 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:

• 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

• 20 years old or older

Exclusion Criteria: Cases applicable to ANY condition of the following:

• Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)

• Others who the principle investigator physician considered to be excluded

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Japan	National Center for Global Health and Medicine	Shinjuku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Global Health and Medicine, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Duration of the treatment efficacy	Evaluate overall HIV management status over time with: Other infections: HBV, HCV, RPR, TPHA; HIV treatment markers: CD4, CD8, CD4/CD8, HIV-RNA; HAART regimens and start dates; Other medications: antibiotics, anticoagulants, antiplatelets, NSAID, steroids; Past medical history; HIV risk behaviors, age, sex	72 weeks	Yes