HIV InfectionsNCT00662181
Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone
An observational study of HIV Infections and HIV-Associated Lipodystrophy Syndrome, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections, HIV-Associated Lipodystrophy Syndrome
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Jan 2009
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants from the HIGH: low study
Who may be able to join
- over 18 years of age
- Participated in and completed the HIGH: low study
- informed consent signed
Who cannot join
- Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Klinisk Forskningscenter, Hvidovre Hospital
Hvidovre, Hvidovre, 2650
Katrine Andersen, Stud.med., 45-36-322-108, katrine.harries.andersen@hvh.regionh.dk
Ove Andersen, MD
About this study
Official title: Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone
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.
- Keywords
- growth hormone, quality of life, fat redistribution, sugar metabolism, fat metabolism, cytokines
- Medical subject headings
- HIV Infections, HIV-Associated Lipodystrophy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| H, NH | HIV positive patients with and without lipodystrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 6 months follow-up
Secondary outcomes (1)
Metabolism
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008 (estimated)
- Study completionJan 2009 (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.
- 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
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ove Andersen, MD, Principal investigator, Klinisk Forskningcenter, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662181
- Sponsor's protocol ID
- H-B-2008-053
- Other IDs
- 2008-41-2145
- Status last verified
- Apr 2008
- First submitted
- 16 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone
- ClinicalTrials.gov ID
- NCT00662181
- Acronym / sponsor ID
- H-B-2008-053
- Keywords
- growth hormone, quality of life, fat redistribution, sugar metabolism, fat metabolism, cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 21 Apr 2008 (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.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H, NH | – | –HIV positive patients with and without lipodystrophy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from the HIGH: low study
Key inclusion criteria (3 listed)
- over 18 years of age
- Participated in and completed the HIGH: low study
- informed consent signed
Key exclusion criteria (1 listed)
- Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study
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
Quality of life
Time frame: 6 months follow-up
1 secondary outcome
Metabolism
Time frame: 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
- The official website for Hvidovre HospitalLink provided by the sponsor.
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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.
Ove Andersen, MD principal investigator
Klinisk Forskningcenter, Hvidovre Hospital
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 HIV-Associated Lipodystrophy Syndrome, run by Hvidovre University Hospital at 1 site in Denmark.
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 3 inclusion and 1 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 Apr 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrine MH Andersen, stud.med. (45-36-322-108, katrine.harries.andersen@hvh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 months follow-up). 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 Apr 2008.