Clinical trial NCT00457665: Mechanisms of Lipodystrophy in HIV-Infected Pateints
Official title: Mecahnisms of Lipodystrophy in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
Lipodystrophy
Treatment Experienced
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: GlaxoSmithKline
First posted: 2007-04-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Drug Regimens on Serum Triglycerides.
timeFrame: 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center Dallas
name: Abhimanyu Garg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: