CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
recombinant human growth hormone +1 moredrug
Likely dose
Recombinant human growth hormone dosed by weight and IGF-1 level, subcutaneously once daily for 18 monthsAI-extracted
Key inclusion· 6
  • Age 18–60 years
  • Confirmed HIV infection
  • Stable antiretroviral therapy for ≥12 weeks before enrollment
  • Waist-to-hip ratio >0.90 (men) or >0.85 (women)
Key exclusion· 5
  • Use of Megace, anti-diabetic agents, GH, anabolic agents, or high-dose glucocorticoids (prednisone >5 mg/day) within 3 months of enrollment
  • Diabetes mellitus
  • Other severe chronic illness
  • Carpal tunnel syndrome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00100698
NCT00100698N/ACompleted

Physiologic Growth Hormone Effects in HIV Lipodystrophy

Massachusetts General Hospital·interventional·Posted Jan 5, 2005·Updated Jul 27, 2010

In Brief

A clinical study evaluating recombinant human growth hormone and placebo for AIDS and HIV Infections. Completed, enrolled 56 participants across 1 site.

Detailed Summary

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAIDS, HIV Infections
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 5, 2005
Enrollment StartJan 1, 2004
Primary CompletionOct 1, 2007
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.5 years ago

Interventions

recombinant human growth hormonedrug

growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months

placebodrug

placebo subcutaneously once a day, 18 months