A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00745823 |
Recruitment Status
:
Terminated
(Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily)
First Posted
: September 3, 2008
Results First Posted
: April 25, 2012
Last Update Posted
: March 21, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Comparator: Raltegravir 400 mg b.i.d. Drug: Experimental: Raltegravir 800 mg q.d. Drug: TRUVADA™ | Phase 3 |
Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.
From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 775 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Raltegravir 400 mg b.i.d. |
Drug: Comparator: Raltegravir 400 mg b.i.d.
Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)
Other Name: ISENTRESS™
Drug: TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
|
Experimental: Raltegravir 800 mg q.d. |
Drug: Experimental: Raltegravir 800 mg q.d.
Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.
Other Name: ISENTRESS™
Drug: TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
|
- Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks [ Time Frame: Week 48 ]
- Number of Participants With One or More Adverse Events at 48 Weeks [ Time Frame: Week 48 ]
- Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks [ Time Frame: Week 48 ]
- Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks [ Time Frame: 48 weeks ]
- Mean Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline and Week 48 ]
- Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks [ Time Frame: Week 96 ]As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
- Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks [ Time Frame: Week 96 ]As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
- Mean Change From Baseline to Week 96 in CD4 Cell Count [ Time Frame: Baseline and Week 96 ]As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
- Number of Participants With One or More Adverse Events at 96 Weeks [ Time Frame: Week 96 ]As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
- Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks [ Time Frame: Week 96 ]As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is male or female 18 years of age or older
- Patient is HIV positive
- Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART
Extension Study:
- The planned extension study did not take place as the study was terminated after the Week 48 analysis.
Exclusion Criteria:
- Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
- Patient has documented resistance to tenofovir or emtricitabine
- Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
- Patient is pregnant or breastfeeding, or expecting to conceive

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745823
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00745823 History of Changes |
Other Study ID Numbers: |
0518-071 2008_543 ( Other Identifier: Merck Registration Number ) CTRI/2009/091/000145 ( Registry Identifier: CTRI ) |
First Posted: | September 3, 2008 Key Record Dates |
Results First Posted: | April 25, 2012 |
Last Update Posted: | March 21, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php |
Keywords provided by Merck Sharp & Dohme Corp.:
HIV Infections Treatment Naïve |
Additional relevant MeSH terms:
Raltegravir Potassium Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |