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 5, 2018
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
Kirby Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)
Total Total of all reporting groups

Baseline Measures
   TDF/FTC+EFV   TDF/FTC+r/ATV   TDF/FTC+AZT+ABC   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   107   105   327 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      115 100.0%      107 100.0%      105 100.0%      327 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      24  20.9%      30  28.0%      22  21.0%      76  23.2% 
Male      91  79.1%      77  72.0%      83  79.0%      251  76.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      35  30.4%      37  34.6%      35  33.3%      107  32.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      10   8.7%      7   6.5%      10   9.5%      27   8.3% 
White      46  40.0%      43  40.2%      35  33.3%      124  37.9% 
More than one race      24  20.9%      20  18.7%      25  23.8%      69  21.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

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

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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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


  More Information

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


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


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

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00335322     History of Changes
Other Study ID Numbers: NCHECR-ALTAIR
First Submitted: June 8, 2006
First Posted: June 9, 2006
Results First Submitted: April 17, 2012
Results First Posted: May 15, 2012
Last Update Posted: September 5, 2018