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Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) (onceMRK)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02131233
First received: May 2, 2014
Last updated: May 17, 2017
Last verified: May 2017
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Results First Received: September 7, 2016
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Investigator, Outcomes Assessor; Primary Purpose: Treatment |
| Condition: |
HIV Infection |
| Interventions: |
Drug: Reformulated Raltegravir Drug: Raltegravir Drug: TRUVADA™ Drug: Placebo to Reformulated Raltegravir Drug: Placebo to Raltegravir |
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 |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| These results stop at the primary data cutoff at Week 48 |
Reporting Groups
| Description | |
|---|---|
| Reformulated Raltegravir | Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks |
| Raltegravir | Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks |
Participant Flow: Overall Study
| Reformulated Raltegravir | Raltegravir | |
|---|---|---|
| STARTED | 533 [1] | 269 [1] |
| Treated | 531 | 266 |
| COMPLETED | 490 [2] | 242 [2] |
| NOT COMPLETED | 43 | 27 |
| Not Treated | 2 | 3 |
| Adverse Event | 6 | 6 |
| Death | 0 | 1 |
| Lack of Efficacy | 4 | 1 |
| Lost to Follow-up | 8 | 4 |
| Non-Compliance With Study Drug | 5 | 4 |
| Physician Decision | 4 | 0 |
| Pregnancy | 2 | 0 |
| Withdrawal by Subject | 12 | 8 |
| [1] | Enrolled participants |
|---|---|
| [2] | Completed to Week 48 |
Show Baseline Characteristics
Outcome Measures
| 1. Primary: | Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48 [ Time Frame: Week 48 ] |
| 2. Secondary: | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ] |
| 3. Secondary: | Percentage of Participants With an Adverse Event (AE) at Week 48 [ Time Frame: Up to Week 48 ] |
| 4. Secondary: | Percentage of Participants With a Drug-Related AE at Week 48 [ Time Frame: Up to Week 48 ] |
| 5. Secondary: | Percentage of Participants With a Serious Adverse Event (SAE) at Week 48 [ Time Frame: Up to Week 48 ] |
| 6. Secondary: | Percentage of Participants With a Serious and Drug-Related AE at Week 48 [ Time Frame: Up to Week 48 ] |
| 7. Secondary: | Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48 [ Time Frame: Up to Week 48 ] |
| 8. Secondary: | Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96 [ Time Frame: Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
| 9. Secondary: | Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
| 10. Secondary: | Percentage of Participants With an AE at Week 96 [ Time Frame: Up to Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
| 11. Secondary: | Percentage of Participants With a Drug-Related AE at Week 96 [ Time Frame: Up to Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
| 12. Secondary: | Percentage of Participants With a SAE at Week 96 [ Time Frame: Up to Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
| 13. Secondary: | Percentage of Participants With a Serious and Drug-Related AE at Week 96 [ Time Frame: Up to Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
| 14. Secondary: | Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 96 [ Time Frame: Up to Week 96 ] |
Results not yet reported. Anticipated Reporting Date:
12/2017
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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| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
| 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:
|
Results Point of Contact:
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT02131233 History of Changes |
| Other Study ID Numbers: |
0518-292 2013-001939-47 ( EudraCT Number ) |
| Study First Received: | May 2, 2014 |
| Results First Received: | September 7, 2016 |
| Last Updated: | May 17, 2017 |