Trial record 3 of 40 for:    " April 09, 2008":" May 09, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Hvidovre University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00662181
First received: April 16, 2008
Last updated: April 18, 2008
Last verified: April 2008
  Purpose

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.


Condition
HIV Infections
HIV-Associated Lipodystrophy Syndrome

Study Type: Observational
Official Title: Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolism [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: May 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
H, NH
HIV positive patients with and without lipodystrophy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants from the HIGH: low study

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662181

Contacts
Contact: Katrine MH Andersen, stud.med. 45-36-322-108 katrine.harries.andersen@hvh.regionh.dk

Locations
Denmark
Klinisk Forskningscenter, Hvidovre Hospital Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Katrine Andersen, Stud.med.    45-36-322-108    katrine.harries.andersen@hvh.regionh.dk   
Principal Investigator: Ove Andersen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Ove Andersen, MD Klinisk Forskningcenter, Hvidovre Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Forskningschef Ove Andersen, Klinisk Forskningscenter, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00662181     History of Changes
Other Study ID Numbers: H-B-2008-053, 2008-41-2145
Study First Received: April 16, 2008
Last Updated: April 18, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
growth hormone
quality of life
fat redistribution
sugar metabolism
fat metabolism
cytokines

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV-Associated Lipodystrophy Syndrome
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014