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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events
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Time Frame 1 year
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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)

Other Adverse Events
    TDF/FTC+EFV     TDF/FTC+r/ATV     TDF/FTC+AZT+ABC  
Total, other (not including serious) adverse events        
# participants affected / at risk     99/115     95/105     91/103  
Blood and lymphatic system disorders        
Anemia † 1      
# participants affected / at risk     0/115 (0.00%)     3/105 (2.86%)     11/103 (10.68%)  
# events     0     3     11  
Reduced blood pressure disorders † 1      
# participants affected / at risk     36/115 (31.30%)     4/105 (3.81%)     10/103 (9.71%)  
# events     36     4     10  
Gastrointestinal disorders        
Gastrointestinal motility and defaecation disorders † 1      
# participants affected / at risk     21/115 (18.26%)     18/105 (17.14%)     16/103 (15.53%)  
# events     21     18     16  
Gastrointestinal signs and symptoms † 1      
# participants affected / at risk     24/115 (20.87%)     33/105 (31.43%)     68/103 (66.02%)  
# events     24     33     68  
General disorders        
Body temperature disorders † 1      
# participants affected / at risk     13/115 (11.30%)     8/105 (7.62%)     6/103 (5.83%)  
# events     13     8     6  
General systems disorder † 1      
# participants affected / at risk     17/115 (14.78%)     15/105 (14.29%)     15/103 (14.56%)  
# events     17     15     15  
Hepatobiliary disorders        
heaptic and hepatobiliary disorders † 1      
# participants affected / at risk     4/115 (3.48%)     46/105 (43.81%)     1/103 (0.97%)  
# events     4     46     1  
Immune system disorders        
Allergic condition † 1      
# participants affected / at risk     11/115 (9.57%)     10/105 (9.52%)     5/103 (4.85%)  
# events     11     10     5  
Infections and infestations        
Bacterial infections † 1      
# participants affected / at risk     4/115 (3.48%)     9/105 (8.57%)     11/103 (10.68%)  
# events     4     9     11  
Fungal infections † 1      
# participants affected / at risk     11/115 (9.57%)     6/105 (5.71%)     8/103 (7.77%)  
# events     11     6     8  
Infections - pathogennot specified † 1      
# participants affected / at risk     45/115 (39.13%)     36/105 (34.29%)     32/103 (31.07%)  
# events     45     36     32  
Viral infections † 1      
# participants affected / at risk     17/115 (14.78%)     11/105 (10.48%)     19/103 (18.45%)  
# events     17     11     19  
Musculoskeletal and connective tissue disorders        
Musculoskeletal and connective tissue disorder † 1      
# participants affected / at risk     11/115 (9.57%)     8/105 (7.62%)     9/103 (8.74%)  
# events     11     8     9  
Nervous system disorders        
headaches † 1      
# participants affected / at risk     11/115 (9.57%)     11/105 (10.48%)     12/103 (11.65%)  
# events     11     11     12  
Psychiatric disorders        
Depressed mood † 1      
# participants affected / at risk     7/115 (6.09%)     1/105 (0.95%)     4/103 (3.88%)  
# events     7     1     4  
Sleep disorders † 1      
# participants affected / at risk     33/115 (28.70%)     8/105 (7.62%)     10/103 (9.71%)  
# events     33     8     10  
Respiratory, thoracic and mediastinal disorders        
Respiratory disroder NEC † 1      
# participants affected / at risk     15/115 (13.04%)     8/105 (7.62%)     15/103 (14.56%)  
# events     15     8     15  
Skin and subcutaneous tissue disorders        
Epidermal and dermal disorders † 1      
# participants affected / at risk     29/115 (25.22%)     14/105 (13.33%)     14/103 (13.59%)  
# events     29     14     14  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)



  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


  More Information