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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 
Overall Participants Analyzed 
[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 (86.09%)   95/105 (90.48%)   91/103 (88.35%) 
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