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Trial registered on ANZCTR


Registration number
ACTRN12610001098022
Ethics application status
Approved
Date submitted
8/06/2006
Date registered
15/12/2010
Date last updated
15/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
ALTAIR - Alternative Antiretroviral Strategies: A Comparison of Three Initial Regimens
Scientific title
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.
Secondary ID [1] 253294 0
NCHCER-ALTAIR
Universal Trial Number (UTN)
Trial acronym
ALTAIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus - HIV 2103 0
HIV+ treatment-naive patients 4569 0
Condition category
Condition code
Infection 4862 4862 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 once daily over 96 weeks
Intervention code [1] 1133 0
Treatment: Drugs
Comparator / control treatment
randomised, open label comparison
Control group
Active

Outcomes
Primary outcome [1] 3049 0
The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-Ribonucleic acid (RNA) 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.
Timepoint [1] 3049 0
week 48 and week 96.
Secondary outcome [1] 5106 0
1.Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL), blood analysis through Polymerase chain reaction (PCR) device.
Timepoint [1] 5106 0
week 48 and week 96
Secondary outcome [2] 5107 0
2.Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400 copies/mL) between treatment arms, blood analysis through Polymerase chain reaction (PCR) device.
Timepoint [2] 5107 0
week 48 and week 96
Secondary outcome [3] 5108 0
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) through Polymerase chain reaction (PCR) device.
Timepoint [3] 5108 0
week 48 and week 96
Secondary outcome [4] 5109 0
Mean change from baseline of absolute CD4+ T cell count blood analysis from laboratory.
Timepoint [4] 5109 0
Weks 48 and 96
Secondary outcome [5] 5110 0
Time to change in randomly assigned therapy (all reasons individually and on aggregate) between treatment arms through data analysis.
Timepoint [5] 5110 0
week 48 and week 96
Secondary outcome [6] 5111 0
Time to first virologic failure or cessation of randomly assigned antiretroviral therapy through data analysis
Timepoint [6] 5111 0
Wek 48 and week 96.
Secondary outcome [7] 5112 0
Mean change from baseline Lipodystrophy Case Definition score
Timepoint [7] 5112 0
weeks 48 and 96
Secondary outcome [8] 5113 0
Mean change from baseline in peripheral and central adipose tissue, as measured by computer tomography and Dual-energy X-ray absorptiometry.
Timepoint [8] 5113 0
weeks 48 and 96
Secondary outcome [9] 5114 0
Mean change from baseline in fasting lipid and glycemic parameters through data analysis
Timepoint [9] 5114 0
weeks 48 and 96
Secondary outcome [10] 5115 0
Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs, between treatment arms. example, rash using data analysis
Timepoint [10] 5115 0
week 48 and week 96
Secondary outcome [11] 5116 0
Comparison of total number of patients with any adverse events (AEs), and the cumulative incidence of AEs, example rash with cessation of randomly assigned therapy between treatment arms.
Timepoint [11] 5116 0
week 48 and week 96
Secondary outcome [12] 5117 0
Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms through virology analysis
Timepoint [12] 5117 0
week 48 and week 96.

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial will be open labelled, i.e. the investigators and the patients will know the randomised allocation. Randomisation will occur electronically upon baseline visit after enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer (random number) generated randomised block design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1580 0
2010
Recruitment outside Australia
Country [1] 339 0
Israel
State/province [1] 339 0
Country [2] 340 0
Thailand
State/province [2] 340 0
Country [3] 341 0
Hong Kong
State/province [3] 341 0
Country [4] 342 0
Malaysia
State/province [4] 342 0
Country [5] 343 0
Singapore
State/province [5] 343 0
Country [6] 344 0
United Kingdom
State/province [6] 344 0
Country [7] 345 0
Germany
State/province [7] 345 0
Country [8] 346 0
Ireland
State/province [8] 346 0
Country [9] 347 0
France
State/province [9] 347 0
Country [10] 348 0
Taiwan, Province Of China
State/province [10] 348 0
Country [11] 349 0
Canada
State/province [11] 349 0
Country [12] 350 0
Chile
State/province [12] 350 0
Country [13] 351 0
Argentina
State/province [13] 351 0
Country [14] 352 0
Mexico
State/province [14] 352 0

Funding & Sponsors
Funding source category [1] 2352 0
Commercial sector/Industry
Name [1] 2352 0
Gilead Sciences, Inc.
Country [1] 2352 0
United States of America
Primary sponsor type
University
Name
The National Centre in HIV Epidemiology and Clinical Research
Address
Level 2 376 Victoria St Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 2133 0
Commercial sector/Industry
Name [1] 2133 0
Gilead Sciences, Inc
Address [1] 2133 0
333 Lakeside Drive Foster City, CA 94404
Country [1] 2133 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6800 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 6800 0
Ethics committee country [1] 6800 0
Australia
Date submitted for ethics approval [1] 6800 0
Approval date [1] 6800 0
11/12/2006
Ethics approval number [1] 6800 0
(HREC 06332)/SVH H06/115

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35913 0
Address 35913 0
Country 35913 0
Phone 35913 0
Fax 35913 0
Email 35913 0
Contact person for public queries
Name 10322 0
Rebekah Puls BSc PhD
Address 10322 0
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst Sydney NSW 2021
Country 10322 0
Australia
Phone 10322 0
+61 2 9385 0900
Fax 10322 0
+61 2 9385 0910
Email 10322 0
rpuls@nchecr.unsw.edu.au
Contact person for scientific queries
Name 1250 0
Sean Emery BSc(Hons) PhD
Address 1250 0
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst
Sydney NSW 2021
Country 1250 0
Australia
Phone 1250 0
+61 2 9385 0900
Fax 1250 0
+61 2 9385 0910
Email 1250 0
semery@nchecr.unsw.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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