A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-018)

This study has been completed.

Study NCT00293267 Information provided by Merck

First Received on February 14, 2006. Last Updated on May 5, 2011 History of Changes

Results First Received: August 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: raltegravir potassium Drug: Comparator: Placebo

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
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]	Does not include patients whom entered the open-label post virological

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

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

Baseline Measures

	Raltegravir 400 mg b.i.d. Plus OBT	Placebo Plus OBT	Total
Number of Participants [units: participants]	232	118	350
Age [units: Years] Mean ( Full Range )	46.1 ( 16 to 74 )	43.7 ( 19 to 64 )	45.3 ( 16 to 74 )
Gender [units: participants]
Female	37	15	52
Male	195	103	298
Race/Ethnicity, Customized [units: participants]
White	174	96	270
Black	18	5	23
Asian	14	5	19
Hispanic	6	1	7
Other	20	11	31
Cluster of Differentiation 4 (CD4) Cell Count [units: cells/mm^3] Mean ( Full Range )	156 ( 1 to 792 )	153 ( 3 to 759 )	155 ( 1 to 792 )
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) [units: copies/mL] Geometric Mean ( Full Range )	40519 ( 441 to 750000 )	31828 ( 200 to 750000 )	37352 ( 200 to 750000 )

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Other Pre-specified:

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

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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 State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00293267 History of Changes
Other Study ID Numbers:	2005_096, MK0518-018
Study First Received:	February 14, 2006
Results First Received:	August 18, 2009
Last Updated:	May 5, 2011
Health Authority:	France: Ministry of Health