Mechanisms of Lipodystrophy in HIV-Infected Pateints

HIV Infections Clinical Trial

Official title:

Mecahnisms of Lipodystrophy in HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457665
• Other study ID #: R01-56583
• Status: Completed
• Phase: Phase 4
• Start date: February 2002
• Est. completion date: October 2014

Study information

• Verified date: May 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.

Description:

A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2014
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• HIV Positive

• No previous antiviral therapy

• 18 to 70 years of age

Exclusion Criteria:

• Patients with opportunistic infections or AIDS.

• Active intravenous drug users.

• Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace.

• Patients with diabetes mellitus.

• Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week).

• Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).

• Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL.

• Anemia (hematocrit <32%).

• Abnormal thyroid function tests.

• Weight loss >10% from baseline in the past year.

• Recent (within the past year), history of suicide attempt.

Related Conditions & MeSH terms

• HIV Infections
• Lipodystrophy

Intervention

Drug:
• Nelfinavir

• Efavirenz

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Bristol-Myers Squibb, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Drug Regimens on Serum Triglycerides.		12 and 24 months