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Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection (PRIMO)

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ClinicalTrials.gov Identifier: NCT03392805
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Giancarlo Ceccarelli, University of Roma La Sapienza

Brief Summary:
exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.

Condition or disease Intervention/treatment Phase
HIV-1-infection Behavioral: physical activity Not Applicable

Detailed Description:

Many studies document that exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. This occurs because a sedentary lifestyle leads to the accumulation of visceral fat, and this is accompanied by an increase in adipokine release and infiltration of adipose tissue by the pro-inflammatory immune cells. Furthermore, the imbalance between immune processes and metabolic processes is associated with the development of insulin resistance, atherosclerosis and neurodegeneration.

The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.

To evaluate this hypothesis, the following parameters will be analyzed: evaluation of immune-activation levels, of metabolic parameters, of cardiac function, of immuno-virological set-up, of dietary intake and of physical performance indices in HIV-positive patients with a sedentary lifestyle; these data will be compared with the values measured in the same HIV positive population with a sedentary lifestyle after three months of regular physical activity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sedentary life style Behavioral: physical activity
beginning of regular physical activity under the supervision of a coach

No Intervention: physically active life style



Primary Outcome Measures :
  1. Delta between Rockport Walking Test value at T0 and T6 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Delta between CD4+CD38+ value at T0 and T6 [ Time Frame: 6 months ]
  2. Delta between CD8+CD38+ value at T0 and T6 [ Time Frame: 6 months ]
  3. Delta between CD4+HLADR+ value at T0 and T6 [ Time Frame: 6 months ]
  4. Delta between CD8+HLADR+ value at T0 and T6 [ Time Frame: 6 months ]
  5. Delta between TNF-α value at T0 and T6 [ Time Frame: 6 months ]
  6. Delta between IL-6 value at T0 and T6 [ Time Frame: 6 months ]
  7. Delta between adiponectin value at T0 and T6 [ Time Frame: 6 months ]
  8. Delta between resistinat T0 and T6 [ Time Frame: 6 months ]
  9. Delta between leptin value at T0 and T6 [ Time Frame: 6 months ]
  10. Delta between maximal Oxygen uptake value at T0 and T6 [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18-60 years
  2. Patients who have signed informed consent
  3. HIV positive patients
  4. Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity.

Exclusion Criteria:

  1. Anemia, pregnancy or any other contraindication to blood sampling and sports activity
  2. Patients suffering from cardiomyopathies and ischemic heart disease

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): NCT03392805


Contacts
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Contact: Gabriella d'Ettorre, MD PhD +39-06-49970324 gabriella.dettorre@uniroma1.it
Contact: Giancarlo Ceccarelli, MD PhD MSc +39-06-49970900 giancarlo.ceccarelli@uniroma1.it

Locations
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Italy
Department of Public Health and Infectious Diseases, University of Rome "La Sapienza" Recruiting
Rome, Italy, 00161
Contact: Gabriella d'Ettorre, MD PhD    +39-06-49970324    gabriella.dettorre@uniroma1.it   
Contact: Giancarlo Ceccarelli, MD PhD MSc    +39-06-49970900    gabriella.dettorre@uniroma1.it   
Principal Investigator: Giancarlo Ceccarelli, MD PhD MSc         
Principal Investigator: Gabriella d'Ettorre, MD PhD         
Principal Investigator: Vincenzo Vullo, MD         
Sponsors and Collaborators
University of Roma La Sapienza

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Responsible Party: Giancarlo Ceccarelli, Reasercher co-PI, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03392805     History of Changes
Other Study ID Numbers: DPHID-UniRoma04
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases