Mechanisms of Lipodystrophy in HIV-Infected Pateints

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Bristol-Myers Squibb; GlaxoSmithKline
• Treatments: Efavirenz; Nelfinavir; Stavudine

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.