Mechanisms of Lipodystrophy in HIV-Infected Pateints

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Efavirenz; Drug: Nelfinavir

• Registration Number: NCT00457665
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Primary Completion: 2007-10
• Study Completion: 2014-10
• Status Verified: 2019-05
• Results First Submitted: 2019-05-08
• Results First Submitted QC: 2019-05-08
• Last Update Submitted: 2019-05-08
• Results First Posted: 2019-07-18
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efavirenz (Sustiva)	Efavirenz	-
Nelfinavir (Viracept)	Nelfinavir	-

Primary Outcome Measures

Name	Time	Method
Effect of Drug Regimens on Serum Triglycerides.	12 and 24 months

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States