HIV InfectionsNCT00149097
Role of the Autonomic Nervous System in HIV-Lipodystrophy
An observational study of HIV Infections and Lipodystrophy-Syndrome, run by Hannover Medical School at 1 site in Germany.
Trial summary
The study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Lipodystrophy-Syndrome
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Jan 2007
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed HIV infection and no active opportunistic infection during the last 2 months.
Who may be able to join
- HIV-infection
- Age above 18 years
- No AIDS defining event during last 6 months
- No infection during last 6 weeks
- No concommitant drug interfering with insulin sensitivity and ANS-activity
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Nervous System Activity in the Pathogenesis of the Lipodystrophy Syndrome in HIV-Infected Patients.
The study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy.
- Conditions
- HIV Infections, Lipodystrophy-Syndrome
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Hector-Stiftung
- Investigators
- Georg MN Behrens, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149097
- Sponsor's protocol ID
- ANS-M26
- Status last verified
- May 2008
- First submitted
- 6 Sep 2005
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Fliers E, Sauerwein HP, Romijn JA, Reiss P, van der Valk M, Kalsbeek A, Kreier F, Buijs RM. HIV-associated adipose redistribution syndrome as a selective autonomic neuropathy. Lancet. 2003 Nov 22;362(9397):1758-60. doi: 10.1016/s0140-6736(03)14858-1.
PubMed 14643128
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Activity in the Pathogenesis of the Lipodystrophy Syndrome in HIV-Infected Patients.
- ClinicalTrials.gov ID
- NCT00149097
- Acronym / sponsor ID
- ANS-M26
- Conditions
- HIV Infections, Lipodystrophy-Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Hector-Stiftung
- Study start
- Mar 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 8 Sep 2005 (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 study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed HIV infection and no active opportunistic infection during the last 2 months.
Key inclusion criteria (5 listed)
- HIV-infection
- Age above 18 years
- No AIDS defining event during last 6 months
- No infection during last 6 weeks
- No concommitant drug interfering with insulin sensitivity and ANS-activity
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
- Background: PubMed 14643128Fliers E, Sauerwein HP, Romijn JA, Reiss P, van der Valk M, Kalsbeek A, Kreier F, Buijs RM. HIV-associated adipose redistribution syndrome as a selective autonomic neuropathy. Lancet. 2003 Nov 22;362(9397):1758-60. doi: 10.1016/s0140-6736(03)14858-1.
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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.
Georg MN Behrens, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Lipodystrophy-Syndrome, run by Hannover Medical School 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 12 May 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149097, which also lists 1 linked publication.
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 12 May 2008.