Trial Outcomes & Findings for ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens (NCT NCT00335322)
NCT ID: NCT00335322
Last Updated: 2019-09-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
329 participants
Primary outcome timeframe
48 weeks
Results posted on
2019-09-26
Participant Flow
Participant milestones
| Measure |
TDF/FTC+EFV
Truvada (fixed dose combination of tenofovir+emtricitabine) + Stocrin efavirenz
|
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
107
|
105
|
|
Overall Study
COMPLETED
|
114
|
105
|
103
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
TDF/FTC+EFV
Truvada (fixed dose combination of tenofovir+emtricitabine) + Stocrin efavirenz
|
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)
|
|---|---|---|---|
|
Overall Study
Randomised but withdrew prior to ART sta
|
1
|
2
|
2
|
Baseline Characteristics
ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens
Baseline characteristics by cohort
| Measure |
TDF/FTC+EFV
n=115 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine)+ Stocrin efavirenz
|
TDF/FTC+r/ATV
n=107 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
|
TDF/FTC+AZT+ABC
n=105 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Modified ITT; all randomised pts who started drug
Outcome measures
| Measure |
TDF/FTC+EFV
n=114 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)
Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
|
TDF/FTC+r/ATV
n=105 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + ritonavir/atazanavir (r/ATV)
Truvada (tenofovir 300mg qd + 200mg qd) once daily Ritonavir/atazanavi 100mg/300mg qd once daily
|
TDF/FTC+AZT+ABC
n=103 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine + abacavir
Truvada (tenofovir 300mg qd + 200mg qd) once daily Zidovudine 250mg/300mg qd taken in two equal doses approx. 12 hours apart Abacavir 600mg qd
|
|---|---|---|---|
|
Time-weighted Mean Change From Baseline Plasma HIV-RNA.
|
-2.59 log copies/mL
Interval -2.67 to -2.41
|
-2.69 log copies/mL
Interval -2.89 to -2.49
|
-2.39 log copies/mL
Interval -2.54 to -2.24
|
SECONDARY outcome
Timeframe: 144 weeksPopulation: Intent to Treat
Outcome measures
| Measure |
TDF/FTC+EFV
n=114 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz)
Truvada (tenofovir 300mg qd + 200mg qd) once daily Efavirenz 600mg qd once daily
|
TDF/FTC+r/ATV
n=105 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + ritonavir/atazanavir (r/ATV)
Truvada (tenofovir 300mg qd + 200mg qd) once daily Ritonavir/atazanavi 100mg/300mg qd once daily
|
TDF/FTC+AZT+ABC
n=103 Participants
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine + abacavir
Truvada (tenofovir 300mg qd + 200mg qd) once daily Zidovudine 250mg/300mg qd taken in two equal doses approx. 12 hours apart Abacavir 600mg qd
|
|---|---|---|---|
|
Time Weighted Mean Change From Baseline Plasma HIV-RNA
|
-2.77 log copies/mL
Interval -2.89 to -2.65
|
-2.88 log copies/mL
Interval -2.99 to -2.78
|
-2.54 log copies/mL
Interval -2.72 to -2.37
|
Adverse Events
TDF/FTC+EFV
Serious events: 14 serious events
Other events: 99 other events
Deaths: 0 deaths
TDF/FTC+r/ATV
Serious events: 8 serious events
Other events: 95 other events
Deaths: 0 deaths
TDF/FTC+AZT+ABC
Serious events: 12 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDF/FTC+EFV
n=115 participants at risk
|
TDF/FTC+r/ATV
n=105 participants at risk
Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
|
TDF/FTC+AZT+ABC
n=103 participants at risk
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
|
|---|---|---|---|
|
Immune system disorders
Autoimmune disorder
|
2.6%
3/115 • Number of events 3 • 1 year
|
0.00%
0/105 • 1 year
|
0.00%
0/103 • 1 year
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.00%
0/103 • 1 year
|
|
Blood and lymphatic system disorders
decreased blood pressure
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 3 • 1 year
|
|
Vascular disorders
Fatal outcome
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.00%
0/103 • 1 year
|
|
Infections and infestations
Fungal infection
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
General disorders
General systems disorder
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 2 • 1 year
|
1.9%
2/103 • Number of events 2 • 1 year
|
|
Infections and infestations
infection class unspecified
|
2.6%
3/115 • Number of events 4 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
1.9%
2/103 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
injury
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Investigations
Investigations, imaging and histopathology
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.00%
0/103 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
0.00%
0/103 • 1 year
|
|
Pregnancy, puerperium and perinatal conditions
maternal complications of pregnancy
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Ovarian and fallopian tube disorders
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pleural disorder
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder NEC
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Seizure
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 2 • 1 year
|
0.00%
0/103 • 1 year
|
|
Injury, poisoning and procedural complications
Therapeutic procedure
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.00%
0/103 • 1 year
|
|
Renal and urinary disorders
Urolithiasis
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Vascular disorders
Vascular hemorrhagic disorders
|
0.87%
1/115 • Number of events 1 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous varices
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
0.00%
0/103 • 1 year
|
|
Infections and infestations
Viral infectious disorder
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Cardiac disorders
cardiac arrhythmias
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 3 • 1 year
|
0.00%
0/103 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 2 • 1 year
|
0.97%
1/103 • Number of events 5 • 1 year
|
|
Psychiatric disorders
Depressed mood and disturbance
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemias and marrow depression
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal motility and defaecation
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
0.00%
0/103 • 1 year
|
|
Immune system disorders
Allergic conditions
|
1.7%
2/115 • Number of events 2 • 1 year
|
0.00%
0/105 • 1 year
|
0.00%
0/103 • 1 year
|
|
Blood and lymphatic system disorders
Hematological and lymphoid tissue therapeutic procedures
|
0.00%
0/115 • 1 year
|
0.00%
0/105 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic and heaptobiliary disroders
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
0.00%
0/103 • 1 year
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/115 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
0.00%
0/103 • 1 year
|
Other adverse events
| Measure |
TDF/FTC+EFV
n=115 participants at risk
|
TDF/FTC+r/ATV
n=105 participants at risk
Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
|
TDF/FTC+AZT+ABC
n=103 participants at risk
Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/115 • 1 year
|
2.9%
3/105 • Number of events 3 • 1 year
|
10.7%
11/103 • Number of events 11 • 1 year
|
|
Immune system disorders
Allergic condition
|
9.6%
11/115 • Number of events 11 • 1 year
|
9.5%
10/105 • Number of events 10 • 1 year
|
4.9%
5/103 • Number of events 5 • 1 year
|
|
General disorders
Body temperature disorders
|
11.3%
13/115 • Number of events 13 • 1 year
|
7.6%
8/105 • Number of events 8 • 1 year
|
5.8%
6/103 • Number of events 6 • 1 year
|
|
Infections and infestations
Bacterial infections
|
3.5%
4/115 • Number of events 4 • 1 year
|
8.6%
9/105 • Number of events 9 • 1 year
|
10.7%
11/103 • Number of events 11 • 1 year
|
|
Blood and lymphatic system disorders
Reduced blood pressure disorders
|
31.3%
36/115 • Number of events 36 • 1 year
|
3.8%
4/105 • Number of events 4 • 1 year
|
9.7%
10/103 • Number of events 10 • 1 year
|
|
Psychiatric disorders
Depressed mood
|
6.1%
7/115 • Number of events 7 • 1 year
|
0.95%
1/105 • Number of events 1 • 1 year
|
3.9%
4/103 • Number of events 4 • 1 year
|
|
Infections and infestations
Fungal infections
|
9.6%
11/115 • Number of events 11 • 1 year
|
5.7%
6/105 • Number of events 6 • 1 year
|
7.8%
8/103 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal motility and defaecation disorders
|
18.3%
21/115 • Number of events 21 • 1 year
|
17.1%
18/105 • Number of events 18 • 1 year
|
15.5%
16/103 • Number of events 16 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
20.9%
24/115 • Number of events 24 • 1 year
|
31.4%
33/105 • Number of events 33 • 1 year
|
66.0%
68/103 • Number of events 68 • 1 year
|
|
General disorders
General systems disorder
|
14.8%
17/115 • Number of events 17 • 1 year
|
14.3%
15/105 • Number of events 15 • 1 year
|
14.6%
15/103 • Number of events 15 • 1 year
|
|
Nervous system disorders
headaches
|
9.6%
11/115 • Number of events 11 • 1 year
|
10.5%
11/105 • Number of events 11 • 1 year
|
11.7%
12/103 • Number of events 12 • 1 year
|
|
Hepatobiliary disorders
heaptic and hepatobiliary disorders
|
3.5%
4/115 • Number of events 4 • 1 year
|
43.8%
46/105 • Number of events 46 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Infections and infestations
Infections - pathogennot specified
|
39.1%
45/115 • Number of events 45 • 1 year
|
34.3%
36/105 • Number of events 36 • 1 year
|
31.1%
32/103 • Number of events 32 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
9.6%
11/115 • Number of events 11 • 1 year
|
7.6%
8/105 • Number of events 8 • 1 year
|
8.7%
9/103 • Number of events 9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disroder NEC
|
13.0%
15/115 • Number of events 15 • 1 year
|
7.6%
8/105 • Number of events 8 • 1 year
|
14.6%
15/103 • Number of events 15 • 1 year
|
|
Psychiatric disorders
Sleep disorders
|
28.7%
33/115 • Number of events 33 • 1 year
|
7.6%
8/105 • Number of events 8 • 1 year
|
9.7%
10/103 • Number of events 10 • 1 year
|
|
Infections and infestations
Viral infections
|
14.8%
17/115 • Number of events 17 • 1 year
|
10.5%
11/105 • Number of events 11 • 1 year
|
18.4%
19/103 • Number of events 19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Epidermal and dermal disorders
|
25.2%
29/115 • Number of events 29 • 1 year
|
13.3%
14/105 • Number of events 14 • 1 year
|
13.6%
14/103 • Number of events 14 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place