Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments nutropin, oral glucose tolerance test, dual energy x-ray absorptiometry (dexa), computed tomography (ct) scan
Phase phase 2/phase 3
Sponsor University of Texas Southwestern Medical Center
Collaborator Genentech
Trial size 20 participants
Trial identifier NCT00286676, 0103-045

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
1) body weight
time frame:
2) lean tissue mass (LTM).
time frame:

Secondary Outcomes

Measure
1) whole body protein turnover (WBPT)
time frame:
2) gluconeogenesis
time frame:
3) bone mineral density and markers of bone turnover
time frame:
4) fat distribution (lipoatrophy)
time frame:
5) thymus size
time frame:
6) T-cell subsets
time frame:
7) TNF-µ level
time frame:

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Principal investigator Dana S Hardin, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.