Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00369941 | A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT) | PHASE3 | COMPLETED | 566 | — | — | Aug 1, 2006 | Feb 1, 2012 | Mar 21, 2017 | - | — |
| NCT00105157 | Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED) | PHASE2 | COMPLETED | 179 | — | — | Mar 1, 2005 | Jul 1, 2009 | Dec 4, 2015 | - | — |
| NCT00100048 | A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED) | PHASE2 | COMPLETED | 206 | — | — | Jan 1, 2005 | Jul 1, 2010 | Sep 9, 2015 | - | — |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 48.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
All participant deaths in the span of 48 weeks on study were recorded.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
An AE was defined as any unfavorable \& unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose.
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
| Arm | Type | Description |
|---|---|---|
| MK-0518 400 mg b.i.d. | EXPERIMENTAL | MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. |
| Efavirenz 600 mg q.h.s. | ACTIVE_COMPARATOR | Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. |
| 1 | EXPERIMENTAL | MK0518 200 mg |
| 2 | EXPERIMENTAL | MK0518 400 mg |
| 3 | EXPERIMENTAL | MK0518 600 mg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| 600 mg monotherapy | EXPERIMENTAL | MK0518 600 mg twice daily |
| 400 mg monotherapy | EXPERIMENTAL | MK0518 400 mg twice daily |
| 200 mg monotherapy | EXPERIMENTAL | MK0518 200 mg twice daily |
| 100 mg monotherapy | EXPERIMENTAL | MK0518 100 mg twice daily |
| placebo monotherapy | PLACEBO_COMPARATOR | Placebo to MK0518 twice daily |
| 600 mg combo therapy | EXPERIMENTAL | MK0518 600 mg + tenofovir + lamivudine |
| 400 mg combo therapy | EXPERIMENTAL | MK0518 400 mg + tenofovir + lamivudine |
| 200 mg combo therapy | EXPERIMENTAL | MK0518 200 mg + tenofovir + lamivudine |
| 100 mg combo therapy | EXPERIMENTAL | MK0518 100 mg + tenofovir + lamivudine |
| EFV combo therapy | ACTIVE_COMPARATOR | efavirenz + tenofovir + lamivudine |
| Name | Type | Description |
|---|---|---|
| MK-0518 | DRUG | 400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks |
| Comparator: efavirenz | DRUG | 600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks |
| Comparator: Truvada | DRUG | One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir) |
| Comparator: Placebo to MK-0518 | DRUG | Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks |
| Comparator: Placebo to efavirenz | DRUG | Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks |
| Comparator: MK0518 | DRUG | MK0518 oral tablets 200 mg b.i.d, for 24 weeks |
| MK0518 | DRUG | MK0518 oral tablets 400 mg b.i.d, for 24 weeks |
| Placebo | DRUG | Placebo to MK0518, oral tablet b.i.d, for 24 weeks |
| Comparator: MK0518 monotherapy | DRUG | MK0518 twice daily for 10 days |
| Comparator: MK0518 combination therapy | DRUG | MK0518 twice daily for 48 weeks |
| Comparator: tenofovir | DRUG | tenofovir 300 mg daily for 48 weeks |
| Comparator: lamivudine | DRUG | lamivudine 300 mg daily for 48 weeks |
| Placebo monotherapy | DRUG | Placebo to MK0518 twice daily |
Inclusion Criteria: * Participant is a male or female at least 18 years of age * Participant is HIV positive * Participant is naïve to antiretroviral therapy (ART) and has not received any ART Exclusion Criteria: * Participant has received approved or experimental antiretroviral agents in the pas...