A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

This study has been completed.

Study NCT00293254 Information provided by Merck

First Received on February 15, 2006. Last Updated on June 8, 2011 History of Changes

Results First Received: August 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
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:

Number of Patients Achieving HIV RNA <400 Copies/mL at Week 16 [ Time Frame: 16 Weeks ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Other Pre-specified:

Number of Patients Achieving HIV RNA <50 Copies/mL at Week 48 [ Time Frame: Week 48 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

Publications:

Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54.

Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00293254 History of Changes
Other Study ID Numbers:	2005_097, MK0518-019
Study First Received:	February 15, 2006
Results First Received:	August 20, 2009
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration