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

History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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 ]

Show Outcome Measure 1

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

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

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)

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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

Results Point of Contact:

Name/Title: Sean Emery
Organization: Kirby Institute
phone: 9385 0900
e-mail: semery@kirby.unsw.edu.au

Publications of Results:

Puls RL, Srasuebkul P, Petoumenos K, Boesecke C, Duncombe C, Belloso WH, Molina JM, Li L, Avihingsanon A, Gazzard B, Cooper DA, Emery S; Altair Study Group. Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Clin Infect Dis. 2010 Oct 1;51(7):855-64.

Winston A, Duncombe C, Li PC, Gill JM, Kerr SJ, Puls R, Petoumenos K, Taylor-Robinson SD, Emery S, Cooper DA; Altair Study Group. Does choice of combination antiretroviral therapy (cART) alter changes in cerebral function testing after 48 weeks in treatment-naive, HIV-1-infected individuals commencing cART? A randomized, controlled study. Clin Infect Dis. 2010 Mar 15;50(6):920-9. Erratum in: Clin Infect Dis. 2010 Sep 1;51(5):638.

Responsible Party:	Kirby Institute
ClinicalTrials.gov Identifier:	NCT00335322 History of Changes
Other Study ID Numbers:	NCHECR-ALTAIR
Study First Received:	June 8, 2006
Results First Received:	April 17, 2012
Last Updated:	April 17, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

To Top