SkIn, Muscle and Bone Aging Determinants in HIV Infected-patients.

Not Applicable

Completed

• Conditions: Marker; Structural; HIV-1-infection
• Interventions: Procedure: DXA (dual-energy x-ray absorptiometric) measurement

• Registration Number: NCT04067219
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

this study consists of the study of markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Detailed Description

Nowadays, the elevated frequency of cancers as well as cardiovascular, neurocognitive and bone diseases seems to denote a process of accelerated aging in the treated HIV-infected population of western countries, who are 40 to 50 years old in median. Markers of age-related alterations should be compared to the distribution among the general population whenever possible, to disentangle the effect of HIV and "normal" ageing or ageing due to other conditions. Common mechanisms should be better understood, more specifically those related to the impact of tobacco, antiretroviral treatments, and nutritional components. For markers of skin, muscle, neurocognitive function and bone ageing, the distribution of the general population is available and, in addition, alteration of these markers might have common mechanisms, such as insufficiency in 25 hydroxy vitamin D or nutritional parameters. Therefore, a joint study of these three organs seems particularly relevant.

This aim is to study markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Study Timeline

• Study Start: 2012-05-03
• Primary Completion: 2013-01-03
• Study Completion: 2013-12-19
• Status Verified: 2019-08
• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• HIV-1 infected patients included in the TISSOS-VIH substudy of the ARNS CO3 Aquitaine Cohort or who had a DXA measurement of the lumbar spine, femoral neck, and total body between 2004 and 2011 at the University Hospital of Bordeaux,
• > 18 years
• Affiliated to the medical insurance
• Having had at least one DXA measurement prior to the SIMBAD study visit
• Written informed consent for the SIMBAD study

Exclusion Criteria

• Hepatitis C virus co-infection
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	DXA (dual-energy x-ray absorptiometric) measurement	HIV-1 infected patients

Primary Outcome Measures

Name	Time	Method
Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters	At the earliest at the inclusion visit and within a 9-month window after inclusion	presence of osteoporosis or osteopenia on DXA (T-score \< -2.5 and \<-1, respectively), locomotor test results \> 2 standard deviations of the mean of the general population, presence of premature hair whitening in patients aged \< 40 years (defined by\>50% of gray hair before the age of 40)