Status:
COMPLETED
ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
The University of New South Wales
Conditions:
Human Immunodeficiency Virus (HIV)
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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...
Detailed Description
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 initia...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00335322
Start Date
February 1 2007
End Date
November 1 2011
Last Update
September 26 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.