Phase 2
N=77
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
HIV-Associated Lipodystrophy Syndrome · Insulin Resistance · HIV Infections · Metabolic Syndrome X · Body Weight Changes
Bottom Line
View on ClinicalTrials.gov: NCT00130286 ↗Enrolled (actual)
77
Serious AEs
6.5%
Results posted
Feb 2014
Primary outcome: Primary: Change in Insulin Sensitivity — 0.20; 1.44; -0.63; 0.14 uU*10^-4*min*ml^-1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rosiglitazone (Drug); Recombinant human growth hormone + rosiglitazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Sensitivity |
0.20; 1.44; -0.63; 0.14 | — |
| SECONDARY Change in Visceral Adipose Tissue Volume |
-1.13; -0.19; -1.15; -0.04 | — |
| SECONDARY Change in Subcutaneous Adipose Tissue Volume |
-0.11; 0.74; -0.38; -0.03 | — |
Summary
The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.
Eligibility Criteria
Inclusion Criteria
- HIV-infected
- On stable Food and Drug Administration (FDA)-approved antiretrovirals for at least 8 weeks
- Excess abdominal fat based on waist and hip measurements done at the screening visit. [waist greater than 34.7 inches (men) or 29.6 inches (women) and waist to hip ratio greater than 0.95 (men) or 0.9 (women)]
- Evidence of insulin resistance (based on fasting glucose and insulin levels done at screening)
- Triglycerides less than 750 mg/dL
Exclusion Criteria
- Pregnancy
- Active AIDS-defining infection or other acute illness, within 30 days of entry.
- Active cancer (except for localized Kaposi's sarcoma) or active brain tumor
- Any diagnosis of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorder associated with fluid retention (examples: cirrhosis, congestive heart failure)
- Untreated or uncontrolled high blood pressure, within 30 days of entry.
- Within 12 weeks of study entry, use of the following:
- Obesity (fat-reducing) drugs.
- Anti-diabetic or insulin-sensitizing drugs (examples: rosiglitazone, pioglitazone, or metformin).
- Systemic glucocorticoids (example: prednisone).
- Growth hormone or any medication for AIDS-associated wasting.
- Systemic chemotherapy, interferon, or radiation therapy.
- Androgenic agents [examples: nandrolone, oxandrolone (Oxandrin) (testosterone replacement therapy is permitted if started more than 30 days before entry)]
- Appetite stimulants (Marinol, Megace, Periactin).
- Use of cholesterol lowering drugs, unless started more than 12 weeks before entry
- Inability to have a magnetic resonance imaging (MRI) scan performed (examples: cardiac pacemaker, intracranial aneurysm clips)
Data sourced from ClinicalTrials.gov (NCT00130286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.