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

HIV-1-infection Clinical Trial

— SIMBAD  

Official title:

Determinants of Skin, Muscle and Bone Aging in HIV-1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067219
• Other study ID #: CHUBX 2011/02
• Status: Completed
• Phase: N/A
• Start date: May 3, 2012
• Est. completion date: December 19, 2013

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 19, 2013
• Est. primary completion date: January 3, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection
• Marker; Structural

Intervention

Procedure:
• DXA (dual-energy x-ray absorptiometric) measurement
DXA, evaluation of muscular function and muscle strength; neurocognitive tests; non invasive analysis of mechanical skin properties; food frequency questionnaire; laboratory assessment (25 hydroxy vitamin D, calcium/phosphate metabolism, bone remodelling markers, T cell activation).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters	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)	At the earliest at the inclusion visit and within a 9-month window after inclusion