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

Primary Purpose

HIV-1-infection

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

physical activity

About this trial

This is an interventional treatment trial for HIV-1-infection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

sedentary life style

physically active life style

Arm Description

Outcomes

Primary Outcome Measures

Delta between Rockport Walking Test value at T0 and T6

Secondary Outcome Measures

Delta between CD4+CD38+ value at T0 and T6

Delta between CD8+CD38+ value at T0 and T6

Delta between CD4+HLADR+ value at T0 and T6

Delta between CD8+HLADR+ value at T0 and T6

Delta between TNF-α value at T0 and T6

Delta between IL-6 value at T0 and T6

Delta between adiponectin value at T0 and T6

Delta between resistinat T0 and T6

Delta between leptin value at T0 and T6

Delta between maximal Oxygen uptake value at T0 and T6

Full Information

NCT ID

NCT03392805

First Posted

January 2, 2018

Last Updated

January 2, 2018

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT03392805

Brief Title

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

Acronym

PRIMO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1-infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sedentary life style

Arm Type

Experimental

Arm Title

physically active life style

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

physical activity

Intervention Description

beginning of regular physical activity under the supervision of a coach

Primary Outcome Measure Information:

Title

Delta between Rockport Walking Test value at T0 and T6

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Delta between CD4+CD38+ value at T0 and T6

Time Frame

6 months

Title

Delta between CD8+CD38+ value at T0 and T6

Time Frame

6 months

Title

Delta between CD4+HLADR+ value at T0 and T6

Time Frame

6 months

Title

Delta between CD8+HLADR+ value at T0 and T6

Time Frame

6 months

Title

Delta between TNF-α value at T0 and T6

Time Frame

6 months

Title

Delta between IL-6 value at T0 and T6

Time Frame

6 months

Title

Delta between adiponectin value at T0 and T6

Time Frame

6 months

Title

Delta between resistinat T0 and T6

Time Frame

6 months

Title

Delta between leptin value at T0 and T6

Time Frame

6 months

Title

Delta between maximal Oxygen uptake value at T0 and T6

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18-60 years Patients who have signed informed consent HIV positive patients Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity. Exclusion Criteria: Anemia, pregnancy or any other contraindication to blood sampling and sports activity Patients suffering from cardiomyopathies and ischemic heart disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gabriella d'Ettorre, MD PhD

Phone

+39-06-49970324

gabriella.dettorre@uniroma1.it

First Name & Middle Initial & Last Name or Official Title & Degree

Giancarlo Ceccarelli, MD PhD MSc

Phone

+39-06-49970900

giancarlo.ceccarelli@uniroma1.it

Facility Information:

Facility Name

Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"

City

Rome

ZIP/Postal Code

00161

Country

Italy

Individual Site Status

Recruiting

Facility Contact: