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

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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)
Enrollment 329

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC
Hide Arm/Group Description [Not Specified] Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
Period Title: Overall Study
Started 115 107 105
Completed 114 105 103
Not Completed 1 2 2
Reason Not Completed
Randomised but withdrew prior to ART sta             1             2             2
Arm/Group Title TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC Total
Hide Arm/Group Description [Not Specified] Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC) Total of all reporting groups
Overall Number of Baseline Participants 115 107 105 327
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 107 participants 105 participants 327 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 107 participants 105 participants 327 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 107 participants 105 participants 327 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%
1.Primary Outcome
Title Time-weighted Mean Change From Baseline Plasma HIV-RNA.
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT; all randomised pts who started drug
Arm/Group Title TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 114 105 103
Mean (95% Confidence Interval)
Unit of Measure: log copies/mL
-2.59
(-2.67 to -2.41)
-2.69
(-2.89 to -2.49)
-2.39
(-2.54 to -2.24)
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 144 weeks
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC
Hide Arm/Group Description [Not Specified] Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV) Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
All-Cause Mortality
TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/115 (12.17%)      8/105 (7.62%)      12/103 (11.65%)    
Blood and lymphatic system disorders       
decreased blood pressure  1  1/115 (0.87%)  1 0/105 (0.00%)  0 1/103 (0.97%)  3
Anemias and marrow depression  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  2
Hematological and lymphoid tissue therapeutic procedures  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Cardiac disorders       
cardiac arrhythmias  1  0/115 (0.00%)  0 1/105 (0.95%)  3 0/103 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal signs and symptoms  1  0/115 (0.00%)  0 1/105 (0.95%)  2 1/103 (0.97%)  5
Gastrointestinal motility and defaecation  1  0/115 (0.00%)  0 1/105 (0.95%)  1 0/103 (0.00%)  0
General disorders       
General systems disorder  1  0/115 (0.00%)  0 1/105 (0.95%)  2 2/103 (1.94%)  2
Hepatobiliary disorders       
Hepatic and heaptobiliary disroders  1  0/115 (0.00%)  0 1/105 (0.95%)  1 0/103 (0.00%)  0
Immune system disorders       
Autoimmune disorder  1  3/115 (2.61%)  3 0/105 (0.00%)  0 0/103 (0.00%)  0
Allergic conditions  1  2/115 (1.74%)  2 0/105 (0.00%)  0 0/103 (0.00%)  0
Infections and infestations       
Bacterial infection  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Fungal infection  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
infection class unspecified  1  3/115 (2.61%)  4 1/105 (0.95%)  1 2/103 (1.94%)  4
Viral infectious disorder  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Mycobacterial infection  1  0/115 (0.00%)  0 1/105 (0.95%)  1 0/103 (0.00%)  0
Injury, poisoning and procedural complications       
Therapeutic procedure  1  1/115 (0.87%)  1 0/105 (0.00%)  0 0/103 (0.00%)  0
Investigations       
Investigations, imaging and histopathology  1  1/115 (0.87%)  1 0/105 (0.00%)  0 0/103 (0.00%)  0
Musculoskeletal and connective tissue disorders       
injury  1  1/115 (0.87%)  1 0/105 (0.00%)  0 1/103 (0.97%)  1
Pleural disorder  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lymphoma  1  0/115 (0.00%)  0 1/105 (0.95%)  1 0/103 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
maternal complications of pregnancy  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Psychiatric disorders       
Seizure  1  0/115 (0.00%)  0 1/105 (0.95%)  2 0/103 (0.00%)  0
Depressed mood and disturbance  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Renal and urinary disorders       
Urolithiasis  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  1
Reproductive system and breast disorders       
Cervix disorder  1  1/115 (0.87%)  1 0/105 (0.00%)  0 0/103 (0.00%)  0
Ovarian and fallopian tube disorders  1  0/115 (0.00%)  0 0/105 (0.00%)  0 1/103 (0.97%)  2
Respiratory, thoracic and mediastinal disorders       
Respiratory disorder NEC  1  1/115 (0.87%)  1 0/105 (0.00%)  0 1/103 (0.97%)  1
Vascular disorders       
Fatal outcome  1  1/115 (0.87%)  1 0/105 (0.00%)  0 0/103 (0.00%)  0
Vascular hemorrhagic disorders  1  1/115 (0.87%)  1 0/105 (0.00%)  0 1/103 (0.97%)  1
Venous varices  1  0/115 (0.00%)  0 1/105 (0.95%)  1 0/103 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TDF/FTC+EFV TDF/FTC+r/ATV TDF/FTC+AZT+ABC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   99/115 (86.09%)      95/105 (90.48%)      91/103 (88.35%)    
Blood and lymphatic system disorders       
Anemia  1  0/115 (0.00%)  0 3/105 (2.86%)  3 11/103 (10.68%)  11
Reduced blood pressure disorders  1  36/115 (31.30%)  36 4/105 (3.81%)  4 10/103 (9.71%)  10
Gastrointestinal disorders       
Gastrointestinal motility and defaecation disorders  1  21/115 (18.26%)  21 18/105 (17.14%)  18 16/103 (15.53%)  16
Gastrointestinal signs and symptoms  1  24/115 (20.87%)  24 33/105 (31.43%)  33 68/103 (66.02%)  68
General disorders       
Body temperature disorders  1  13/115 (11.30%)  13 8/105 (7.62%)  8 6/103 (5.83%)  6
General systems disorder  1  17/115 (14.78%)  17 15/105 (14.29%)  15 15/103 (14.56%)  15
Hepatobiliary disorders       
heaptic and hepatobiliary disorders  1  4/115 (3.48%)  4 46/105 (43.81%)  46 1/103 (0.97%)  1
Immune system disorders       
Allergic condition  1  11/115 (9.57%)  11 10/105 (9.52%)  10 5/103 (4.85%)  5
Infections and infestations       
Bacterial infections  1  4/115 (3.48%)  4 9/105 (8.57%)  9 11/103 (10.68%)  11
Fungal infections  1  11/115 (9.57%)  11 6/105 (5.71%)  6 8/103 (7.77%)  8
Infections - pathogennot specified  1  45/115 (39.13%)  45 36/105 (34.29%)  36 32/103 (31.07%)  32
Viral infections  1  17/115 (14.78%)  17 11/105 (10.48%)  11 19/103 (18.45%)  19
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorder  1  11/115 (9.57%)  11 8/105 (7.62%)  8 9/103 (8.74%)  9
Nervous system disorders       
headaches  1  11/115 (9.57%)  11 11/105 (10.48%)  11 12/103 (11.65%)  12
Psychiatric disorders       
Depressed mood  1  7/115 (6.09%)  7 1/105 (0.95%)  1 4/103 (3.88%)  4
Sleep disorders  1  33/115 (28.70%)  33 8/105 (7.62%)  8 10/103 (9.71%)  10
Respiratory, thoracic and mediastinal disorders       
Respiratory disroder NEC  1  15/115 (13.04%)  15 8/105 (7.62%)  8 15/103 (14.56%)  15
Skin and subcutaneous tissue disorders       
Epidermal and dermal disorders  1  29/115 (25.22%)  29 14/105 (13.33%)  14 14/103 (13.59%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Inadequate sample size for true comparison of non-inferiority
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
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