The Use of Nutropin Depot in HIV-infected Adult Males

HIV Infection Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00286676
• Other study ID #: 0103-045
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: February 1, 2006
• Est. completion date: February 1, 2006

Study information

• Verified date: December 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2006
• Est. primary completion date: February 1, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Nutropin

Procedure:
• Oral Glucose Tolerance Test

• Dual Energy X-ray Absorptiometry (DEXA)

• Computed Tomography (CT) Scan

Locations

Country	Name	City	State
United States	Aston Ambulatory Care Center	Dallas	Texas
United States	Parkland Health & Hospital System	Dallas	Texas
United States	Veteran's Affairs Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) body weight
Primary	2) lean tissue mass (LTM).
Primary	Testosterone levels
Secondary	1) whole body protein turnover (WBPT)
Secondary	2) gluconeogenesis
Secondary	3) bone mineral density and markers of bone turnover
Secondary	4) fat distribution (lipoatrophy)
Secondary	5) thymus size
Secondary	6) T-cell subsets
Secondary	7) TNF-µ level