BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.

This study has been completed.

Sponsor:

Collaborators:

Bristol-Myers Squibb

Merck

Information provided by (Responsible Party):

Cal Cohen, Community Research Initiative of New England

ClinicalTrials.gov Identifier:

NCT00931801

First received: June 30, 2009

Last updated: March 14, 2013

Last verified: March 2013

Results First Received: February 5, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV
Interventions:	Drug: atazanavir/raltegravir Drug: atazanavir/tenofovir/emtricitabine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was initiated on 15 APR 2010 and enrolled subjects through 31 JAN 2011. Recruitment and screening took place at 10 participating sites (9 medical clinics and 1 clinical research organization). 43 subjects were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 7 participants that did not meet eligibility criteria (either due to disallowed concomitant medication use or safety labs outside of the required parameters). 2 of those 7 subjects re-screened at a later date and were confirmed eligible. 2 subjects withdrew consent after the screening visit but prior to starting the assigned treatment.

Reporting Groups

	Description
Control Arm	atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Intervention Arm No.1	atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Intervention Arm No.2	atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily

Participant Flow: Overall Study

	Control Arm	Intervention Arm No.1	Intervention Arm No.2
STARTED	14	15	14
COMPLETED	13	14	10
NOT COMPLETED	1	1	4
Adverse Event	0	0	1
Lost to Follow-up	0	1	0
Withdrawal by Subject	1	0	0
Confirmed Virologic Failure	0	0	3

Baseline Characteristics

Reporting Groups

	Description
Control Arm	atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Intervention Arm No.1	atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Intervention Arm No.2	atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Total	Total of all reporting groups

Baseline Measures

	Control Arm	Intervention Arm No.1	Intervention Arm No.2	Total
Number of Participants [units: participants]	14	15	14	43
Age [units: years] Mean ± Standard Deviation	43.5 ± 11.6	47.6 ± 11.5	46.6 ± 6.6	45.9 ± 10.1
Gender [units: participants]
Female	2	2	1	5
Male	12	13	13	38
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	6	2	5	13
Not Hispanic or Latino	8	13	9	30
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0
Asian	1	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	3	3	3	9
White	9	12	11	32
More than one race	0	0	0	0
Unknown or Not Reported	1	0	0	1
Region of Enrollment [units: participants]
United States	14	15	14	43
Mean CD4 [units: cells/mm3] Mean ± Standard Deviation	544.6 ± 197.7	518.5 ± 198.9	533.9 ± 198.3	532.0 ± 193.8