The Use of Nutropin Depot in HIV-infected Adult Males

NCT00286676 | Withdrawn Phase 2

• 1 other identifier: 0103-045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (3)

• 1) body weight

• 2) lean tissue mass (LTM).

• Testosterone levels

Secondary Outcomes (7)

• 1) whole body protein turnover (WBPT)

• 2) gluconeogenesis

• 3) bone mineral density and markers of bone turnover

• 4) fat distribution (lipoatrophy)

• 5) thymus size

Interventions

Nutropin DRUG

Oral Glucose Tolerance Test PROCEDURE

Dual Energy X-ray Absorptiometry (DEXA) PROCEDURE

Computed Tomography (CT) Scan PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult males ≥ 18 years of age
• mild to moderate lipoatrophy
• stable protease inhibitor therapy for at least six months.

You may not qualify if:

• Con-current supra-infection with acute illness defined by fever or bacterial culture
• malignancy
• females
• diabetes mellitus
• CNS tumors.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (3)

Aston Ambulatory Care Center

Dallas, Texas, 75390, United States

Location

Parkland Health & Hospital System

Dallas, Texas, 75390, United States

Location

Veteran's Affairs Medical Center

Dallas, Texas, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Human Growth Hormone; Glucose Tolerance Test; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Officials

• Dana S Hardin, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

US (3)