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
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
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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
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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  
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 ]

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
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Time Frame 1 year
Additional Description 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)

Serious Adverse Events
    TDF/FTC+EFV     TDF/FTC+r/ATV     TDF/FTC+AZT+ABC  
Total, serious adverse events        
# participants affected / at risk     14/115 (12.17%)     8/105 (7.62%)     12/103 (11.65%)  
Blood and lymphatic system disorders        
decreased blood pressure † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     1/103 (0.97%)  
# events     1     0     3  
Anemias and marrow depression † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     2  
Hematological and lymphoid tissue therapeutic procedures † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Cardiac disorders        
cardiac arrhythmias † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     3     0  
Gastrointestinal disorders        
Gastrointestinal signs and symptoms † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     1/103 (0.97%)  
# events     0     2     5  
Gastrointestinal motility and defaecation † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     1     0  
General disorders        
General systems disorder † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     2/103 (1.94%)  
# events     0     2     2  
Hepatobiliary disorders        
Hepatic and heaptobiliary disroders † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     1     0  
Immune system disorders        
Autoimmune disorder † 1      
# participants affected / at risk     3/115 (2.61%)     0/105 (0.00%)     0/103 (0.00%)  
# events     3     0     0  
Allergic conditions † 1      
# participants affected / at risk     2/115 (1.74%)     0/105 (0.00%)     0/103 (0.00%)  
# events     2     0     0  
Infections and infestations        
Bacterial infection † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Fungal infection † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
infection class unspecified † 1      
# participants affected / at risk     3/115 (2.61%)     1/105 (0.95%)     2/103 (1.94%)  
# events     4     1     4  
Viral infectious disorder † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Mycobacterial infection † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     1     0  
Injury, poisoning and procedural complications        
Therapeutic procedure † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     0/103 (0.00%)  
# events     1     0     0  
Investigations        
Investigations, imaging and histopathology † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     0/103 (0.00%)  
# events     1     0     0  
Musculoskeletal and connective tissue disorders        
injury † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     1/103 (0.97%)  
# events     1     0     1  
Pleural disorder † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Lymphoma † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     1     0  
Pregnancy, puerperium and perinatal conditions        
maternal complications of pregnancy † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Psychiatric disorders        
Seizure † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     2     0  
Depressed mood and disturbance † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Renal and urinary disorders        
Urolithiasis † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     1  
Reproductive system and breast disorders        
Cervix disorder † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     0/103 (0.00%)  
# events     1     0     0  
Ovarian and fallopian tube disorders † 1      
# participants affected / at risk     0/115 (0.00%)     0/105 (0.00%)     1/103 (0.97%)  
# events     0     0     2  
Respiratory, thoracic and mediastinal disorders        
Respiratory disorder NEC † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     1/103 (0.97%)  
# events     1     0     1  
Vascular disorders        
Fatal outcome † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     0/103 (0.00%)  
# events     1     0     0  
Vascular hemorrhagic disorders † 1      
# participants affected / at risk     1/115 (0.87%)     0/105 (0.00%)     1/103 (0.97%)  
# events     1     0     1  
Venous varices † 1      
# participants affected / at risk     0/115 (0.00%)     1/105 (0.95%)     0/103 (0.00%)  
# events     0     1     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)




  Other Adverse Events


  Limitations and Caveats
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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


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