Chronic HIV infection MedDRA version: 8.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Truvada
Product Name: Truvada
Pharmaceutical Form: Tablet
INN or Proposed INN: Emtricitabine
CAS Number: 143491-57-0
Current Sponsor code: NCHECR
Concentration unit: mg milligram(s)
Concen
Sponsors
University of New South Wales
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria, 1. HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6 months from date of randomisation. 2. Aged > 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate). 3. Antiretroviral treatment naïve. 4. Qualifying plasma HIV RNA = 2,000 copies/mL and a CD4+ T cell count of = 50 cells/µL. 5. No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing). 6. Calculated creatinine clearance (CLCr) >= 70 mL/min (Cockcroft-Gault formula). Male: (140 - age in years) x (wt in kg) = CLCr (mL/min) 72 x (serum creatinine in mg/dL) Female: (140 - age in years) x (wt in kg) x 0.85 = CLCr (mL/min) 72 x (serum creatinine in mg/dL) 7. Able to provide written informed consent. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria, 1. The following laboratory variables, a). absolute neutrophil count (ANC) 5 x upper limit of normal (ULN) 2. Evidence of HLA-B57 or HLA B*5701 positivity 3. Pregnant or nursing mothers. 4. Current use of human growth hormone, testosterone or other anabolic steroid. 5. Current use of any prohibited medications as described in product specific information. 6. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation. 7. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial. 8. Patients unlikely to be able to remain in follow-up for the protocol-defined period. 9. Patients with known renal insufficiency. 10. Patients with obstructive liver disease. 11. Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days). 12. History of acute or chronic pancreatitis. 13. Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease. 14. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The time-weighted average change in log viral load from baseline at week 48;Main Objective: The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-RNA, and safety, of three strategic regimens of initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. ;Secondary Objective: Secondary objectives of this study will be to undertake a range of analyses 1. to describe virological response to therapy 2. changes in CD4+ T lymphocyte numbers 3. change in randomly assigned therapy between treatment arms. 4. change from baseline Lipodystrophy Case Definition score 5. Mean change from baseline in fasting lipid and glycemic parameters 6. Incidence and type of SAEs 7. Incidence and type of AEs. 8. Patterns of genotypic HIV resistance 9. Describe aspects of immune reconstitution disease. 10. Adherence to therapy 11. Quality of life | — |
Countries
France, Germany, Ireland, United Kingdom
Outcome results
None listed