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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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-ยต 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):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutropin | Drug | |||
| Oral Glucose Tolerance Test | Procedure | |||
| Dual Energy X-ray Absorptiometry (DEXA) | Procedure | |||
| Computed Tomography (CT) Scan | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 1) body weight | ||
| 2) lean tissue mass (LTM). | ||
| Testosterone levels |
| Measure | Description | Time Frame |
|---|---|---|
| 1) whole body protein turnover (WBPT) | ||
| 2) gluconeogenesis | ||
| 3) bone mineral density and markers of bone turnover |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana S Hardin, MD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston Ambulatory Care Center | Dallas | Texas | 75390 | United States | ||
| Parkland Health & Hospital System |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D005951 | Glucose Tolerance Test |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| 4) fat distribution (lipoatrophy) |
| 5) thymus size |
| 6) T-cell subsets |
| 7) TNF-ยต level |
| Dallas |
| Texas |
| 75390 |
| United States |
| Veteran's Affairs Medical Center | Dallas | Texas | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |