ongitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study
- Conditions
- HIV
- Registration Number
- EUCTR2005-004021-26-GB
- Lead Sponsor
- niversity Hospital Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method