HIV InfectionPhase 2/3NCT00286676
The Use of Nutropin Depot in HIV-infected Adult Males
A Phase 2/3 study testing Nutropin, Oral Glucose Tolerance Test and Dual Energy X-ray Absorptiometry (DEXA) in people with HIV Infection, run by University of Texas Southwestern Medical Center at 3 sites in United States.
Trial summary
This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 with lipoatrophy), treated with Nutropin AQ subcutaneously. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infection
- What is being tested?
- Nutropin, Oral Glucose Tolerance Test and Dual Energy X-ray Absorptiometry (DEXA)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2006to 1 Feb 2006
- Phase
- Phase 2/3
- 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
Who may be able to join
- adult males ≥ 18 years of age
- mild to moderate lipoatrophy
- stable protease inhibitor therapy for at least six months.
Who cannot join
- Con-current supra-infection with acute illness defined by fever or bacterial culture
- malignancy
- females
- diabetes mellitus
- CNS tumors.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aston Ambulatory Care Center
Dallas, Texas, 75390
Parkland Health & Hospital System
Dallas, Texas, 75390
Veteran's Affairs Medical Center
Dallas, Texas
About this study
This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 with lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is to determine the effect of GH depot on body weight and lean tissue mass (LTM).
The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2) gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such as glucose intolerance and edema, will be monitored at every visit.
Read the detailed description
Patients will be recruited from the HIV clinics at University of Texas Southwestern Medical School and the Veterans Administration Hospital by direct invitation from Dr. Margolis (adult HIV clinic director and University director for the NIH-ACTG). We will recruit 20 HIV-infected adult males who have been treated with stable protease inhibitor therapy regimen for the past 6 months. One half of the subjects will have evidence of lipoatrophy (as defined by the ACTG29). Each subject will have baseline (BL) measures made, and then will start on GH depot or subcutaneous AQ. Patients will be followed every two weeks for the first six weeks, then every three months for the remainder of the study. Study parameters to be measured include (also see flow chart in appendix):
- Baseline, 3, 6 and 12 months: OGTT, testosterone level, whole body protein turnover, hepatic glucose production and gluconeogenesis measures, DXA scan (for measuring lean tissue mass and bone density), bone mineral markers, resting energy expenditure, calorie count, T cell subsets, TNF µ levels.
- Every 3 months: IGF-1 (will obtain every 2 weeks for first 6 weeks), body weight, and post-prandial glucose level.
- Baseline, 6 and 12 months- CT scan for measurement of thymus size
- Conditions
- HIV Infection
- Being tested
- Nutropin, Oral Glucose Tolerance Test, Dual Energy X-ray Absorptiometry (DEXA), Computed Tomography (CT) Scan
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutropinDrug
Oral Glucose Tolerance TestProcedure or surgery
Dual Energy X-ray Absorptiometry (DEXA)Procedure or surgery
Computed Tomography (CT) ScanProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
1) body weight
2) lean tissue mass (LTM).
Testosterone levels
Secondary outcomes (7)
1) whole body protein turnover (WBPT)
2) gluconeogenesis
3) bone mineral density and markers of bone turnover
4) fat distribution (lipoatrophy)
5) thymus size
6) T-cell subsets
7) TNF-µ level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study start1 Feb 2006 (estimated)
- Primary completion1 Feb 2006 (estimated)
- Study completion1 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Dana S Hardin, MD, Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286676
- Sponsor's protocol ID
- 0103-045
- Status last verified
- Dec 2018
- First submitted
- 1 Feb 2006
- Last updated
- 26 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nutropin Depot in HIV-infected Adult Males
- ClinicalTrials.gov ID
- NCT00286676
- Acronym / sponsor ID
- 0103-045
- Conditions
- HIV Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Feb 2006 (estimated)
- Primary completion
- 1 Feb 2006 (estimated)
- Study completion
- 1 Feb 2006 (estimated)
- First posted
- 3 Feb 2006 (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.
This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 with lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is to determine the effect of GH depot on body weight and lean tissue mass (LTM).
The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2) gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such as glucose intolerance and edema, will be monitored at every visit.
Detailed description
Patients will be recruited from the HIV clinics at University of Texas Southwestern Medical School and the Veterans Administration Hospital by direct invitation from Dr. Margolis (adult HIV clinic director and University director for the NIH-ACTG). We will recruit 20 HIV-infected adult males who have been treated with stable protease inhibitor therapy regimen for the past 6 months. One half of the subjects will have evidence of lipoatrophy (as defined by the ACTG29). Each subject will have baseline (BL) measures made, and then will start on GH depot or subcutaneous AQ. Patients will be followed every two weeks for the first six weeks, then every three months for the remainder of the study. Study parameters to be measured include (also see flow chart in appendix):
- Baseline, 3, 6 and 12 months: OGTT, testosterone level, whole body protein turnover, hepatic glucose production and gluconeogenesis measures, DXA scan (for measuring lean tissue mass and bone density), bone mineral markers, resting energy expenditure, calorie count, T cell subsets, TNF µ levels.
- Every 3 months: IGF-1 (will obtain every 2 weeks for first 6 weeks), body weight, and post-prandial glucose level.
- Baseline, 6 and 12 months- CT scan for measurement of thymus size
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult males ≥ 18 years of age
- mild to moderate lipoatrophy
- stable protease inhibitor therapy for at least six months.
Key exclusion criteria (5 listed)
- Con-current supra-infection with acute illness defined by fever or bacterial culture
- malignancy
- females
- diabetes mellitus
- CNS tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutropin | Drug | – |
| Oral Glucose Tolerance Test | Procedure or surgery | – |
| Dual Energy X-ray Absorptiometry (DEXA) | Procedure or surgery | – |
| Computed Tomography (CT) Scan | Procedure or surgery | – |
Primary outcome
1) body weight
2) lean tissue mass (LTM).
Testosterone levels
7 secondary outcomes
1) whole body protein turnover (WBPT)
2) gluconeogenesis
3) bone mineral density and markers of bone turnover
4) fat distribution (lipoatrophy)
5) thymus size
6) T-cell subsets
7) TNF-µ level
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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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.
Dana S Hardin, MD principal investigator
University of Texas, Southwestern Medical Center at Dallas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nutropin, Oral Glucose Tolerance Test and Dual Energy X-ray Absorptiometry (DEXA) in people with HIV Infection, run by University of Texas Southwestern Medical Center at 3 sites in United States.
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 5 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: withdrawn, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
1) body weight. The study lists 3 primary outcomes in all. 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 26 Dec 2018.