ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz); Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV); Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
Intervention description: Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily; Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food); Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; Zidovudine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Abacavir; Efavirenz
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 329.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus (HIV)

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 positive by licensed diagnostic test with presumed duration of infection > 6
             months from date of randomisation.

          -  Aged > 16 years of age (or minimum age as determined by local regulations or as legal
             requirements dictate).

          -  Antiretroviral treatment naïve.

          -  Qualifying plasma HIV RNA > 2,000 copies/mL and a CD4+ T cell count of ≥ 50 cells/µL.

          -  No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing).

          -  Calculated creatinine clearance (CLCr) greater than or equal to 70 mL/min
             (Cockcroft-Gault formula).

          -  Able to provide written informed consent.

        Exclusion Criteria:

          -  The following laboratory variables,

               -  absolute neutrophil count (ANC) < 750 cells/µL

               -  haemoglobin < 8.0 g/dL

               -  platelet count < 50,000 cells/µL

               -  serum AST, ALT > 5 x upper limit of normal (ULN)

               -  serum bilirubin > 1.5 x ULN

          -  Pregnant or nursing mothers.

          -  Current use of human growth hormone, testosterone or other anabolic steroid.

          -  Current use of any prohibited medications as described in product specific
             information.

          -  Acute therapy for serious infection or other serious medical illness (in the judgement
             of the site Principal Investigator) requiring systemic treatment and/or
             hospitalisation.

          -  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.

          -  Patients unlikely to be able to remain in follow-up for the protocol-defined period.

          -  Patients with known renal insufficiency.

          -  Patients with obstructive liver disease.

          -  Patients with intractable diarrhoea (six loose stools/day for at least seven
             consecutive days).

          -  History of acute or chronic pancreatitis.

          -  Presence of cardiomyopathy (due to any cause) or any significant cardiovascular
             disease, such as unstable ischemic heart disease.

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).