The Use of Nutropin Depot in HIV-infected Adult Males
| Status: | Withdrawn |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/27/2018 |
| Start Date: | February 1, 2006 |
| End Date: | February 1, 2006 |
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.
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.
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
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
Inclusion Criteria:
- adult males ≥ 18 years of age
- mild to moderate lipoatrophy
- stable protease inhibitor therapy for at least six months.
Exclusion Criteria:
- Con-current supra-infection with acute illness defined by fever or bacterial culture
- malignancy
- females
- diabetes mellitus
- CNS tumors.
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