NCT00662181

Brief Summary

A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism, fat-redistribution and cytokines. The study will use the participants control visit, and the only additional examination will be the danish MOS-HIV questionnaire.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

5 months

First QC Date

April 16, 2008

Last Update Submit

April 18, 2008

Conditions

HIV InfectionsHIV-Associated Lipodystrophy Syndrome

Keywords

growth hormonequality of lifefat redistributionsugar metabolismfat metabolismcytokines

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    6 months follow-up

Secondary Outcomes (1)

  • Metabolism

    6 months follow-up

Study Arms (1)

H, NH

HIV positive patients with and without lipodystrophy

Eligibility Criteria

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

Participants from the HIGH: low study

You may qualify if:

  • over 18 years of age
  • Participated in and completed the HIGH: low study
  • informed consent signed

You may not qualify if:

  • Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinisk Forskningscenter, Hvidovre Hospital

Hvidovre, Hvidovre, 2650, Denmark

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsHIV-Associated Lipodystrophy Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ove Andersen, MD

    Klinisk Forskningcenter, Hvidovre Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrine MH Andersen, stud.med.

CONTACT

45-36-322-108katrine.harries.andersen@hvh.regionh.dk

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

DK(1)