Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III; First Patient In: 22-Mar-2006; Last Patient Last Visit for Week 48: 03-Aug-2007 63 sites (Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, and Thailand), 61 of which randomized patients.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients failed prior antiretroviral therapy (HIV RNA >1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.

Reporting Groups

	Description
Raltegravir 400 mg b.i.d. Plus OBT	No text entered.
Placebo Plus OBT	No text entered.

Participant Flow:   Overall Study

	Raltegravir 400 mg b.i.d. Plus OBT	Placebo Plus OBT
STARTED	234	118
Treated	232	118
Continuing in Double-Blind	193	50
COMPLETED	193[1]	50
NOT COMPLETED	41	68
Never Treated	2	0
Adverse Event	1	1
Death	3	3
Lack of Efficacy	0	2
Lost to Follow-up	1	1
Withdrawal by Subject	1	1
Entered Virological Failure Phase	33	60

1.  Primary:

Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16   [ 16 Weeks ]

2.  Secondary:

Change From Baseline in HIV RNA at Week 16   [ Baseline and Week 16 ]

3.  Secondary:

Change From Baseline in HIV RNA at Week 48   [ Baseline and Week 48 ]

4.  Secondary:

Change From Baseline in CD4 Cell Count at Week 16   [ Baseline and Week 16 ]

5.  Secondary:

Change From Baseline in CD4 Cell Count at Week 48   [ Baseline and Week 48 ]

6.  Other Pre-specified:

Proportion of Patients Achieving HIV RNA <50 Copies/mL at Week 48   [ 48 weeks ]