AIDS, HIV Infections
Conditions
Keywords
maraviroc, osteoclasts, Receptors, CCR5, Chemokine CCL5
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.
Detailed 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.
Interventions
DRUGMaraviroc
Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks
Sponsors
National Center for Global Health and Medicine, Japan
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of maraviroc's effect to bone metabolism and bone mineral density | 78 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the treatment efficacy | 72 weeks | 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 |
Countries
Japan
Outcome results
None listed