HIV
Conditions
Interventions
Trade Name: SUSTIVA
Product Name: Efavirenz
Pharmaceutical Form: Capsule*
Trade Name: COMBIVIR
Product Name: AZT/3TC
Ph
Sponsors
University Hospital Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV positive patients > 18 years Antiretroviral naive Patients who are going to start anti-viral treatment (as determined by the current BHIVA guidelines and their clinician) will be invited to participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Fasting glucose >6.1 mmol/L (or a non-diabetic glucose tolerance test if fasting glucose 6.1-6.9 mmol/L), weekly alcohol intake > 28 unit (male) or 21 units (female) 73, taking lipid lowering drugs, glucocorticoids, or any drugs which affect lipid metabolism (patients should be off lipid lowering drugs for at least 6 weeks), hypothyroidism, creatinine >150 mmol/L and ALT, AST >five times upper limit of normal, anaemia, >10% loss in body weight in the preceding six months, an AIDS defining disease within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Peripheral fat loss and disturbances in fat and glucose metabolism often follows antiretroviral therapy of HIV. Fat loss caused by damage to cell mitochondria, may play a central role in metabolic abnormalaties consequently to HIV antiviral therapy. In this study we will randomise patients equally to receive one of two nationally and internationally recognised and recommended antiretroviral regimens (1. Combivir + Sustiva or 2. Truvada + Sustiva). Comparison will be made between the two regimens regarding: plasma lipids, adipocyte hormones (adiponectin and leptin), insulin resistance, plasma cytokines, adipocyte mitochondrial content and activity, adipocyte genes regulating lipid and glucose metabolism, post-heparin lipoprotein lipase and hepatic lipase activity, and body fat distribution. Comparisons will be made before treatment and after 6 and 18-24 months ; Primary end point(s): Plasma lipids, insulin resistance, serum adiponectin and leptin levels, serum cytokines, post-heparin lipoprotein lipase and hepatic lipase activity Also measured will be adipocyte mitochondrial DNA content, COX complex activity, uncoupling proteins 1, 2 and 3, a number of adipocyte genes controlling glucose and fat metabolism. Body fat changes as maesured by DEXA scan and single slice abdominal CT. ;Secondary Objective: Inter patient comparison between baseline values and values at 6 and at 18-24 months | — |
Countries
United Kingdom
Outcome results
None listed