A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies

This study is ongoing, but not recruiting participants.

Study NCT00293254 Information provided by Merck

First Received: February 15, 2006 Last Updated: November 12, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	HIV Infections
Interventions:	Drug: Comparator: raltegravir potassium Drug: Comparator: placebo

Participant Flow

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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: 08-Mar-2006; Last Patient Last Visit for Week 48: 31-Jul-2007 53 sites (US, Brazil, Canada, Colombia, and Mexico).

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: 08-Mar-2006; Last Patient Last Visit for Week 48: 31-Jul-2007

53 sites (US, Brazil, Canada, Colombia, and Mexico).

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	Raltegravir 400 mg twice a day (b.i.d.) plus Optimized Background Therapy (OBT)
Placebo Plus OBT	Placebo plus Optimized Background Therapy (OBT)

Participant Flow: Overall Study

	Raltegravir 400 mg b.i.d. Plus OBT	Placebo Plus OBT
STARTED	232	119
Treated	230	119
COMPLETED	177	55
NOT COMPLETED	55	64
Never Treated	2	0
Adverse Event	1	0
Death	6	3
Lack of Efficacy	2	2
Lost to Follow-up	3	1
Withdrawal by Subject	5	1
Moved or trial terminated at site	1	0
Entered Post Virological Failure phase	35	57

Baseline Characteristics

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Reporting Groups

	Description
Raltegravir 400 mg b.i.d. Plus OBT	Raltegravir 400 mg twice a day (b.i.d.) plus Optimized Background Therapy (OBT)
Placebo Plus OBT	Placebo plus Optimized Background Therapy (OBT)

Baseline Measures

	Raltegravir 400 mg b.i.d. Plus OBT	Placebo Plus OBT	Total
Number of Participants [units: participants]	230	119	349
Age [units: Years] Mean ( Full Range )	45.3 ( 16 to 67 )	46.5 ( 17 to 70 )	45.7 ( 16 to 70 )
Gender [units: participants]
Female	20	12	32
Male	210	107	317
Race/Ethnicity, Customized [units: Participants]
White	126	77	203
Black	48	21	69
Asian	2	1	3
Hispanic	47	18	65
Native American	1	0	1
Other	6	2	8
Cluster of Differentiation 4 (CD4) Cell Count [units: cells/mm^3] Mean ( Full Range )	146 ( 1 to 757 )	163 ( 0 to 674 )	152 ( 0 to 757 )
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) [units: copies/mL] Geometric Mean ( Full Range )	48366 ( 200 to 750000 )	47850 ( 200 to 750000 )	48190 ( 200 to 750000 )

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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Measure Type	Secondary
Measure Title	Change From Baseline in HIV RNA at Week 16
Measure Description	Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)
Time Frame	Baseline and Week 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA <400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy

Reporting Groups

	Description
Raltegravir 400 mg b.i.d. Plus OBT	Raltegravir 400 mg twice a day (b.i.d.) plus Optimized Background Therapy (OBT)
Placebo Plus OBT	Placebo plus Optimized Background Therapy (OBT)

Measured Values

	Raltegravir 400 mg b.i.d. Plus OBT	Placebo Plus OBT
Number of Participants Analyzed [units: participants]	230	119
Change From Baseline in HIV RNA at Week 16 [units: HIV RNA (log10 copies/mL)] Mean ( 95% Confidence Interval )	-1.92 ( -2.05 to -1.78 )	-1.06 ( -1.27 to -0.86 )

No statistical analysis provided for Change From Baseline in HIV RNA at Week 16

3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Other Pre-specified:

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

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Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_097, MK0518-019
Study First Received:	February 15, 2006
Results First Received:	August 20, 2009
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00293254 History of Changes
Health Authority:	United States: Food and Drug Administration