Phase 4 N=56 Randomized Triple-blind Treatment

Mechanisms of Lipodystrophy in HIV-Infected Pateints

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00457665 ↗

Enrolled (actual)

Serious AEs

5.4%

Results posted

Jul 2019

Primary outcome: Primary: Effect of Drug Regimens on Serum Triglycerides. — 228.0; 230.4; 293.4; 290.0 mg/dL — p=0.94

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nelfinavir (Drug); Efavirenz (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Drug Regimens on Serum Triglycerides.	228.0; 230.4; 293.4; 290.0	0.94

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.

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 10% from baseline in the past year.
Recent (within the past year), history of suicide attempt.

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Data sourced from ClinicalTrials.gov (NCT00457665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.