ALTAIR - Alternative Antiretroviral Strategies: A Comparison of Three Initial Regimens

A randomised, open-label, 96-week study comparing the safety and efficacy of three different combination antiretroviral regimens as initial therapy for human immunodeficiency virus infection.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001098022

Acronym

ALTAIR

Enrollment

300

Registered

2010-12-15

Start date

2007-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Arm 1: Truvada (300 mg tenofovir, 200 mg emtricitabine) once daily + 600 mg Stocrin (efavirenz) oral capsule once daily over 96 weeks Arm 2: Truvada (300 mg tenofovir, 200 mg emtricitabine) once daily + 100 mg/300 mg ritonavir/atazanavir (r/ATV) once daily (taken with food) oral capsule over 96 weeks Arm 3: Truvada (300 mg tenofovir, 200 mg emtricitabine) once daily + 250mg/300mg zidovudine (ZDV) daily (taken in two equal doses approximately 12 hours apart) + 600 mg abacavir (ABC) oral capsule

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

1. HIV-1 positive by licensed diagnostic test with presumed duration of infection > or equal to 6 months from date of randomisation. 2. Antiretroviral treatment naïve. 3. Qualifying plasma HIV RNA > or equal to 2,000 copies/mL and a CD4+ T cell count of at 50 cells/microlitre. 4. No evidence of harbouring a drug resistant HIV (based upon genotypic drug testing). 5. Calculated creatinine clearance (CLCr) > or equal to 70 mL/min (Cockcroft-Gault formula). 6.Able to provide written informed consent.

Exclusion criteria

1. The following laboratory variables, a). absolute neutrophil count (ANC) < or equal to 750 cells/Microlitre b). haemoglobin < or equal to 8.0 g/dL c). platelet count < or equal to 50,000 cells/microlitre d). serum AST, ALT > or equal to 5 x upper limit of normal (ULN) e). serum bilirubin > or equal to 1.5 x ULN 2. Pregnant or nursing mothers. 3. Current use of human growth hormone, testosterone or other anabolic steroid. 4. Current use of any prohibited medications as described in product specific information. 5. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation. 6. 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. 7. Patients unlikely to be able to remain in follow-up for the protocol-defined period. 8. Patients with known renal insufficiency. 9. Patients with obstructive liver disease. 10. Patients with intractable diarrhoea (six loose stools/day for at least seven consecutive days). 11. History of acute or chronic pancreatitis. 12. Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease. 13. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated).

Outcome results