Phase 4
N=327
ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens
Human Immunodeficiency Virus (HIV)
Bottom Line
View on ClinicalTrials.gov: NCT00335322 ↗Enrolled (actual)
327
Serious AEs
10.5%
Results posted
May 2012
Primary outcome: Primary: Time-weighted Mean Change From Baseline Plasma HIV-RNA. — -2.59; -2.69; -2.39 log copies/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz) (Drug); Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) (Drug); Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Kirby Institute
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Mean Change From Baseline Plasma HIV-RNA. |
-2.59; -2.69; -2.39 | — |
| SECONDARY Time Weighted Mean Change From Baseline Plasma HIV-RNA |
-2.77; -2.88; -2.54 | — |
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) 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).
Data sourced from ClinicalTrials.gov (NCT00335322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.