Therapeutic Approaches to HAART-Induced Lipodystrophy

NCT00461552 | Completed Phase 2 Results DMC

• 1 other identifier: 063656
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.

Conditions

HIV Infections; Lipodystrophy

Keywords

Lipodystrophy; HIV; HAART; HIV Lipodystrophy Syndrome; Lipodystrophy syndrome; HIV-Associated Lipodystrophy; HIV-Associated Lipodystrophy Syndrome; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Fasting Serum Triglycerides

  6 months

Secondary Outcomes (1)

• Body Weight (kg)

  6 months

Study Arms (2)

Leptin

ACTIVE COMPARATOR

Leptin weight and gender based dose, sub-cutaneous, twice daily. Leptin versus placebo for entire 6 months double-blind.

Drug: Leptin

Placebo

PLACEBO COMPARATOR

Placebo , sub-Q injection twice daily.

Other: Placebo

Interventions

Leptin DRUG

weight based, sub-cutaneous injection, twice daily

Also known as: Metreleptin

Leptin

Placebo OTHER

weight based, sub-cutaneous injection, twice daily

Placebo

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

HIV Infections; Lipodystrophy; HIV-Associated Lipodystrophy Syndrome

Interventions

Leptin; metreleptin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Adipokines; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Abhimanyu Garg
• Organization: UT Southwestern Medical Center

abhimanyu.garg@utsouthwestern.edu

214-648-2895

Study Officials

• Abhimanyu Garg, M.D.

  Univeristy of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Division Nutrition and Metabolic Diseases, Professor Internal Medicine

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: January 1, 2003
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 9, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-05

Locations

US (1)