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A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:
Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection

Clinical Trial Summary

The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy.

Clinical Trial Description

This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC. ;

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002245
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Completed
Phase Phase 3
Start date April 1999
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