SkIn, Muscle and Bone Aging Determinants in HIV Infected-patients. (SIMBAD)
|ClinicalTrials.gov Identifier: NCT04067219|
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection Marker; Structural||Procedure: DXA (dual-energy x-ray absorptiometric) measurement||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 participants|
|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|
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).
- 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)
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
|Principal Investigator:||Patrick MERCIE, Pr||University Hospital, Bordeaux|