Text Size

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

This study has been completed.
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00335322
First received: June 8, 2006
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
Results First Received: April 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus (HIV)
Interventions: 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)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TDF/FTC+EFV No text entered.
TDF/FTC+r/ATV Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
TDF/FTC+AZT+ABC Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)

Participant Flow:   Overall Study
    TDF/FTC+EFV     TDF/FTC+r/ATV     TDF/FTC+AZT+ABC  
STARTED     115     107     105  
COMPLETED     114     105     103  
NOT COMPLETED     1     2     2  
Randomised but withdrew prior to ART sta                 1                 2                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
TDF/FTC+EFV No text entered.
TDF/FTC+r/ATV Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
TDF/FTC+AZT+ABC Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
Total Total of all reporting groups

Baseline Measures
    TDF/FTC+EFV     TDF/FTC+r/ATV     TDF/FTC+AZT+ABC     Total  
Number of Participants  
[units: participants]
 		  115     107     105     327  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     115     107     105     327  
>=65 years     0     0     0     0  
Gender  
[units: participants]
 		       
Female     24     30     22     76  
Male     91     77     83     251  
Race (NIH/OMB)  
[units: participants]
 		       
American Indian or Alaska Native     0     0     0     0  
Asian     35     37     35     107  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     10     7     10     27  
White     46     43     35     124  
More than one race     24     20     25     69  
Unknown or Not Reported     0     0     0     0  



  Outcome Measures

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

2.  Secondary:   Compare the Safety of Three Strategic Regimens of Initial ART Containing a Fixed Dose Formulation of Tenofovir and Emtricitabine, With Either Efavirenz or Ritonavir Boosted Atazanavir or Zidovudine Plus Abacavir.   [ Time Frame: 144 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Inadequate sample size for true comparison of non-inferiority  


Results Point of Contact:  
Name/Title: Sean Emery
Organization: Kirby Institute
phone: 9385 0900
e-mail: semery@kirby.unsw.edu.au


Publications of Results:


Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00335322     History of Changes
Other Study ID Numbers: NCHECR-ALTAIR
Study First Received: June 8, 2006
Results First Received: April 17, 2012
Last Updated: April 17, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration