Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335322
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : May 15, 2012
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
Kirby Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Drug: 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) Phase 4

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 initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. (Primary comparisons are regimen I versus II and I versus III as described below).

I. tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) + emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC) + zidovudine (ZDV) + abacavir (ABC)

Secondary objectives of this study will be to undertake a range of analyses including but not limited to the following,

  1. Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL) at week 48 and week 96 between treatment arms.
  2. Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400 copies/mL) between treatment arms.
  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).
  4. Mean change from baseline of absolute CD4+ T cell count at weeks 48 and 96 between treatment arms.
  5. Time to change in randomly assigned therapy (all reasons individually and on aggregate) between treatment arms.
  6. Time to first virologic failure (defined as #3 above) or cessation of randomly assigned antiretroviral therapy.
  7. Mean change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between treatment arms.
  8. Mean change from baseline in peripheral and central adipose tissue, as measured by CT and DEXA at weeks 48 and 96 between treatment arms.
  9. Mean change from baseline in fasting lipid and glycemic parameters at weeks 48 and 96 between treatment arms.
  10. Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs, between treatment arms.
  11. Comparison of total number of patients with any adverse events (AEs), and the cumulative incidence of AEs, associated with cessation of randomly assigned therapy between treatment arms.
  12. Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms.
  13. Describe aspects of immune reconstitution disease.
  14. Adherence to therapy and associations with virologic outcomes between treatment arms.
  15. Comparison of quality of life between treatment arms.

Following the result of the scheduled week 48 data analysis, the protocol steering committee amended the study protocol as follows:

  • Patients on Arms I and II will remain on the current study drugs
  • Patients on Arm III may be switched at the physician's discretion to either Arm I or II
  • There will be a protocol amendment to include one extra follow up visit at week 144 for all patients, regardless of treatment arm or current treatment
  • All patients are to be encouraged to stay on the study up to week 144, to maximize follow up on study.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection.
Study Start Date : February 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1
Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin efavirenz)
 Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)
Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
Active Comparator: 2
Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
 Drug: Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
Tuvada (tenofovir 300mg qd + 200mg qd) once daily ritoanvir/atazanavir 100mg/300mg qd once daily (taken with food)
Experimental: 3
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
 Drug: Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
Tuvada (tenofovir 300mg qd + 200mg qd) once daily zidovudine 250mg/300mg qd (taken in two equal doses approximately 12 hours apart) Abacavir 600mg qd


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time-weighted Mean Change From Baseline Plasma HIV-RNA. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Time Weighted Mean Change From Baseline Plasma HIV-RNA [ Time Frame: 144 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335322


Sponsors and Collaborators
Kirby Institute
The University of New South Wales
Investigators
Layout table for investigator information
Principal Investigator: David A Cooper, AO DSc MD FRACP FRCPA FRCP Kirby Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00335322    
Other Study ID Numbers: NCHECR-ALTAIR
First Posted: June 9, 2006    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Kirby Institute:
Human Immunodeficiency Virus (HIV)
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Ritonavir
 Atazanavir Sulfate
Tenofovir
Zidovudine
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Abacavir
Efavirenz
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents