HIV InfectionsPhase 2/3NCT00910936
Exercise for Patients With HIV Infections
A Phase 2/3 study testing Exercise in people with HIV Infections and Lipodystrophy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Lipodystrophy, Inflammation
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Feb 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65
- HIV infection
- Antiviral therapy
- Understanding of written German
Who cannot join
- Diabetes mellitus
- All conditions which can be aggravated by exercise
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Berlin, State of Berlin, 12200
Fernando Dimeo, MD, +493084452098, fernando.dimeo@charite.de
About this study
Official title: Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.
The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.
- Conditions
- HIV Infections, Lipodystrophy, Inflammation
- Being tested
- Exercise
- Keywords
- HIV, Exercise, Inflammation, Quality of life, Lipodystrophia
- Medical subject headings
- HIV Infections, Lipodystrophy, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
12 weeks endurance training, 3 times weekly for 35 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (VO2max)
Measured: At recruitment and after 12 weeks
Secondary outcomes (3)
Quality of life
Measured: At recruitment and after 12 weeks
Indicators of fat metabolism
Measured: At recruitment and after 12 weeks
Markers of inflammation
Measured: At recruitment and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Fernando Dimeo, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910936
- Sponsor's protocol ID
- EA04/050/07
- Status last verified
- Dec 2009
- First submitted
- 29 May 2009
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.
- ClinicalTrials.gov ID
- NCT00910936
- Acronym / sponsor ID
- EA04/050/07
- Conditions
- HIV Infections, Lipodystrophy, Inflammation
- Keywords
- HIV, Exercise, Inflammation, Quality of life, Lipodystrophia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65
- HIV infection
- Antiviral therapy
- Understanding of written German
Key exclusion criteria (2 listed)
- Diabetes mellitus
- All conditions which can be aggravated by exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise12 weeks endurance training, 3 times weekly for 35 minutes | Behavioural | Intervention |
Primary outcome
Maximal oxygen uptake (VO2max)
Time frame: At recruitment and after 12 weeks
3 secondary outcomes
Quality of life
Time frame: At recruitment and after 12 weeks
Indicators of fat metabolism
Time frame: At recruitment and after 12 weeks
Markers of inflammation
Time frame: At recruitment and after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Dimeo, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exercise in people with HIV Infections and Lipodystrophy, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Dimeo, MD (+493084452098, fernando.dimeo@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (VO2max) (time frame: At recruitment and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2009.