Status:
COMPLETED
Therapeutic Approaches to HAART-Induced Lipodystrophy
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
HIV Infections
Lipodystrophy
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
Brief Summary
To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated ...
Detailed Description
Patients with HAART-induced lipodystrophy report loss of subcutaneous (sc) fat from the extremities and face and excess fat accumulation in the neck and truncal region. They also are predisposed to me...
Eligibility Criteria
Inclusion
- Inclusion Criteria - General inclusion:
- Age \> 14 years
- HIV infection being treated with HIV-1 protease inhibitors for \>6 months currently, or previous protease inhibitor therapy of at least 2 years duration with development of lipodystrophy and current stable therapy preferably for past 4 months.
- Fasting serum triglycerides \> 200 mg/dL
- Exclusion Criteria - General exclusion:
- Acute, ongoing AIDS-defining opportunistic infections.
- Blood CD4 positive lymphocyte count \< 200/mm3
- Known liver disease due to causes other than nonalcoholic steatohepatitis with elevation of liver transaminases by more than two and a half times above the upper limits of normal (SGOT\>105 U/L, SGPT\>120 U/L) or total bilirubin (\>1.5 mg/dL).
- Hematocrit of less than 30%.
- Current alcohol abuse (\>7 drinks or 210 g per wk for women and \>14 drinks or 420 g per wk for men).
- Current substance abuse.
- Uncontrolled diabetes mellitus with fasting plasma glucose \> 180 mg/dL or hemoglobin A1c \> 9%.
- History of weight loss during the last 3 months.
- Use of anorexiogenic drugs, thiazolidinediones, anabolic steroids and human growth hormone.
- Major Neuro-psychiatric illnesses impeding competence or compliance.
- Pregnant and lactating women.
- Cancer excluding skin cancer other than melanoma.
- Acute medical illnesses precluding participation in the studies.
- Chronic renal insufficiency with serum creatinine \> 2 mg/dL.
- Untreated thyroid disorders such as hypothyroidism and hyperthyroidism. Each of the 4 treatment arms has additional specific inclusion and exclusion criteria
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00461552
Start Date
January 1 2003
End Date
September 1 2014
Last Update
May 9 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390