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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067219
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Marker; Structural Procedure: DXA (dual-energy x-ray absorptiometric) measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determinants of Skin, Muscle and Bone Aging in HIV-1 Infected Patients
Actual Study Start Date : May 3, 2012
Actual Primary Completion Date : January 3, 2013
Actual Study Completion Date : December 19, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Single arm
HIV-1 infected patients
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).




Primary Outcome Measures :
  1. Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067219


Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Patrick MERCIE, Pr University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04067219    
Other Study ID Numbers: CHUBX 2011/02
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Alterations