Clinical trial NCT00286676: The Use of Nutropin Depot in HIV-infected Adult Males
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: HIV Infection
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-02-03
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 1) body weight
measure: 2) lean tissue mass (LTM).
measure: Testosterone levels
Secondary outcomes:
measure: 1) whole body protein turnover (WBPT)
measure: 2) gluconeogenesis
measure: 3) bone mineral density and markers of bone turnover
measure: 4) fat distribution (lipoatrophy)
measure: 5) thymus size
measure: 6) T-cell subsets
measure: 7) TNF-µ level
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Aston Ambulatory Care Center
state: Texas
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
city: Dallas
country: United States
facility: Veteran's Affairs Medical Center
state: Texas
Study officials:
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Dana S Hardin, MD
role: PRINCIPAL_INVESTIGATOR
References: