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Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02275780
First received: October 23, 2014
Last updated: June 13, 2017
Last verified: June 2017
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Purpose
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI). Participants will receive double-blind treatment during the 96-week Base Study. Eligible participants in either of the Base Study groups will continue to receive the doravirine-containing regimen open label for an additional 96 weeks in the Extension Study. The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be assessed.
| Condition | Intervention | Phase |
|---|---|---|
| HIV-1 | Drug: Doravirine Drug: Darunavir Drug: Ritonavir Drug: TRUVADA™ or EPZICOM™/KIVEXA™ | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA™ or EPZICOM™/KIVEXA™, in Treatment-Naïve HIV-1 Infected Subjects |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Percentage of participants achieving HIV-1 RNA <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
Secondary Outcome Measures:
- Percentage of participants achieving HIV-1 RNA <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
- Change from baseline in cluster of differentiation 4 (CD4) cell counts at Week 48 [ Time Frame: Baseline and Week 48 ]
- Change from baseline in CD4 cell counts at Week 96 [ Time Frame: Baseline and Week 96 ]
- Change from baseline in fasting low density lipoprotein cholesterol (LDL-C) at Week 48 [ Time Frame: Baseline and Week 48 ]
- Change from baseline in fasting non-high density lipoprotein cholesterol (non-HDL-C) at Week 48 [ Time Frame: Baseline and Week 48 ]
- Change from baseline in fasting high density lipoprotein cholesterol (HDL-C) at Week 48 [ Time Frame: Baseline and Week 48 ]
- Change from baseline in fasting total cholesterol at Week 48 [ Time Frame: Baseline and Week 48 ]
- Change from baseline in fasting triglycerides at Week 48 [ Time Frame: Baseline and Week 48 ]
- Percentage of participants with any adverse event (AE) [ Time Frame: Up to 14 day post study (up to 98 weeks) ]
- Percentage of participants with any serious adverse event (SAE) [ Time Frame: Up to 14 day post study (up to 98 weeks) ]
- Percentage of participants with any drug-related AE [ Time Frame: Up to 14 day post study (up to 98 weeks) ]
- Percentage of participants with any SAE and drug-related AE [ Time Frame: Up to 14 day post study (up to 98 weeks) ]
- Percentage of participants who discontinued treatment due to an AE [ Time Frame: Up to 96 weeks ]
- Percentage of Participants Achieving HIV-1 RNA <40 copies/mL at Week 48 [ Time Frame: Week 48 ]
- Percentage of Participants Achieving HIV-1 RNA <40 copies/mL at Week 96 [ Time Frame: Week 96 ]
| Estimated Enrollment: | 680 |
| Actual Study Start Date: | December 1, 2014 |
| Estimated Study Completion Date: | November 23, 2018 |
| Primary Completion Date: | September 29, 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Doravirine 100 mg
Double-blind Doravirine 100 mg administered orally once daily + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered orally once daily, or once every 2 days for 96 weeks in the Base Study. Eligible participants may continue in the Extension Study with open-label Doravirine 100 mg administered orally once daily + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered orally once daily, or once every 2 days for an additional 96 weeks.
|
Drug: Doravirine
Doravirine 100 mg tablet administered orally once daily
Drug: TRUVADA™ or EPZICOM™/KIVEXA™
The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate, or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine. Either tablet can be administered orally once daily, or TRUVADA™, can be administered once every 2 days.
|
|
Active Comparator: Darunavir 800 mg and Ritonavir 100 mg
Double-blind Darunavir 800 mg and Ritonavir 100 mg administered orally once daily + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered orally, once daily, or once every two days for 96 weeks. Eligible participants may continue in the Extension Study with open-label Doravirine 100 mg administered orally once daily + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered orally once daily, or once every 2 days for an additional 96 weeks.
|
Drug: Doravirine
Doravirine 100 mg tablet administered orally once daily
Drug: Darunavir
Darunavir 800 mg tablet administered orally once daily
Drug: Ritonavir
Ritonavir 100 mg tablet administered orally once daily
Drug: TRUVADA™ or EPZICOM™/KIVEXA™
The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate, or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine. Either tablet can be administered orally once daily, or TRUVADA™, can be administered once every 2 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is HIV-1 positive and has HIV treatment indicated based on physician assessment.
- Has received no (0 days of) antiretroviral therapy (ART), including investigational antiretroviral agents.
- Is considered clinically stable with no signs or symptoms of active infection for at least 2 weeks prior to the start of treatment.
- Female is highly unlikely to become pregnant, or male is highly unlikely to impregnate a partner because they are not of reproductive potential, or agree to practice abstinence or use acceptable contraception for up to 14 days after the last dose of study drug.
- Eligibility for the Extension Study at the Week 96 visit: 1) completed the Week 96 visit, 2) derived benefit from participation through Week 96 in the opinion of the investigator, 3) is a clinically-appropriate candidate for 96 weeks of treatment with the Extension Study regimen.
Exclusion Criteria:
- Uses or has had a recent history of using recreational or illicit drugs.
- Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1.
- Has documented or known resistance to study drugs including MK-1439, darunavir, ritonavir, emtricitabine, tenofovir, abacavir and/or lamivudine.
- Has participated in a study with an investigational compound/device within the prior month, or anticipates doing so during this study.
- Has used systemic immunosuppressive therapy or immune modulators within the prior 30 days, or anticipates doing so during this study.
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs.
- Has a current (active) diagnosis of acute hepatitis due to any cause.
- Is pregnant, breastfeeding or expecting to conceive at any time during the study.
- Female who expects to donate eggs, or male who expects to donate sperm at any time during the study.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02275780
Please refer to this study by its ClinicalTrials.gov identifier: NCT02275780
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT02275780 History of Changes |
| Other Study ID Numbers: |
1439-018 2014-001127-69 ( EudraCT Number ) |
| Study First Received: | October 23, 2014 |
| Last Updated: | June 13, 2017 |
Additional relevant MeSH terms:
|
Ritonavir Darunavir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 23, 2017