Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection.
In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.
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. (Primary comparisons are regimen I versus II and I versus III as
described below).
I. tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) +
emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC)
+ zidovudine (ZDV) + abacavir (ABC)
Secondary objectives of this study will be to undertake a range of analyses including but not
limited to the following,
1. Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL) at week 48 and week
96 between treatment arms.
2. Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400
copies/mL) between treatment arms.
3. Time to virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL (and 400
copies/mL) after confirmed < 50 copies/mL (where time = 0 if patient never achieves
plasma virus load < 50 or <400 copies/mL).
4. Mean change from baseline of absolute CD4+ T cell count at weeks 48 and 96 between
treatment arms.
5. Time to change in randomly assigned therapy (all reasons individually and on aggregate)
between treatment arms.
6. Time to first virologic failure (defined as #3 above) or cessation of randomly assigned
antiretroviral therapy.
7. Mean change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between
treatment arms.
8. Mean change from baseline in peripheral and central adipose tissue, as measured by CT
and DEXA at weeks 48 and 96 between treatment arms.
9. Mean change from baseline in fasting lipid and glycemic parameters at weeks 48 and 96
between treatment arms.
10. Comparison of total number of patients with any serious adverse events (SAEs), and the
cumulative incidence of SAEs, between treatment arms.
11. Comparison of total number of patients with any adverse events (AEs), and the cumulative
incidence of AEs, associated with cessation of randomly assigned therapy between
treatment arms.
12. Patterns of genotypic HIV resistance associated with virological treatment failure
across treatment arms.
13. Describe aspects of immune reconstitution disease.
14. Adherence to therapy and associations with virologic outcomes between treatment arms.
15. Comparison of quality of life between treatment arms.
Following the result of the scheduled week 48 data analysis, the protocol steering committee
amended the study protocol as follows:
- Patients on Arms I and II will remain on the current study drugs
- Patients on Arm III may be switched at the physician's discretion to either Arm I or II
- There will be a protocol amendment to include one extra follow up visit at week 144 for
all patients, regardless of treatment arm or current treatment
- All patients are to be encouraged to stay on the study up to week 144, to maximize
follow up on study.
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