Status:
COMPLETED
Mechanisms of Lipodystrophy in HIV-Infected Pateints
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
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 with...
Eligibility Criteria
Inclusion
- HIV Positive
- No previous antiviral therapy
- 18 to 70 years of age
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00457665
Start Date
February 1 2002
End Date
October 1 2014
Last Update
July 18 2019
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390