The Use of Nutropin Depot in HIV-infected Adult Males

NCT ID: NCT00286676

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-01
• Study Completion Date: 2006-02-01

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Nutropin

Intervention Type: DRUG

Oral Glucose Tolerance Test

Intervention Type: PROCEDURE

Dual Energy X-ray Absorptiometry (DEXA)

Intervention Type: PROCEDURE

Computed Tomography (CT) Scan

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Dana S Hardin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Locations

Aston Ambulatory Care Center

Dallas, Texas, United States

Parkland Health & Hospital System

Dallas, Texas, United States

Veteran's Affairs Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

0103-045

Identifier Type: -

Identifier Source: org_study_id