The Use of Nutropin Depot in HIV-infected Adult Males
Ključne riječi
Sažetak
Opis
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
Datumi
| Posljednja provjera: | 11/30/2018 |
| Prvo podneseno: | 01/31/2006 |
| Predviđena prijava poslana: | 01/31/2006 |
| Prvo objavljeno: | 02/02/2006 |
| Posljednje ažuriranje poslano: | 12/20/2018 |
| Posljednje ažuriranje objavljeno: | 12/25/2018 |
| Stvarni datum početka studija: | 01/31/2006 |
| Procijenjeni datum primarnog završetka: | 01/31/2006 |
| Procijenjeni datum završetka studije: | 01/31/2006 |
Stanje ili bolest
Intervencija / liječenje
Drug: Nutropin
Procedure: Oral Glucose Tolerance Test
Procedure: Dual Energy X-ray Absorptiometry (DEXA)
Procedure: Computed Tomography (CT) Scan
Faza
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | Male |
| Prihvaća zdrave volontere | Da |
| Kriteriji | 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. |
Ishod
Primarne mjere ishoda
1. 1) body weight [undefined]
2. 2) lean tissue mass (LTM). [undefined]
3. Testosterone levels [undefined]
Sekundarne mjere ishoda
1. 1) whole body protein turnover (WBPT) [undefined]
2. 2) gluconeogenesis [undefined]
3. 3) bone mineral density and markers of bone turnover [undefined]
4. 4) fat distribution (lipoatrophy) [undefined]
5. 5) thymus size [undefined]
6. 6) T-cell subsets [undefined]
7. 7) TNF-µ level [undefined]
