NCT00149097

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

First QC Date

September 6, 2005

Last Update Submit

May 6, 2008

Conditions

HIV InfectionsLipodystrophy-Syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed HIV infection and no active opportunistic infection during the last 2 months.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 14643128BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Georg MN Behrens, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

March 1, 2005

Study Completion

January 1, 2007

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

DE(1)