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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_096 |
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This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.
Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0518 monotherapy | Drug | MK0518 twice daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL) | Baseline and Day 10 |
| Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | 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. | 10 days |
| Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | Week 24 | |
| Number of Patients With Clinical Adverse Experiences (CAEs) | 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. | 48 weeks |
| Number of Patients With Serious CAEs (Cohort I and II Combined) | 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 | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | Week 24 | |
| Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | 48 weeks | |
| Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs |
Inclusion Criteria:
Extension Studies:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17133211 | Background | Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956. | |
| 18090280 |
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Patients with Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) of at least 5000 copies/mL and cluster of differentiation 4 (CD4) cell counts of at least 100 cells/mm3. All patients must have met laboratory criteria.
206 enrolled; 5 from Cohort I did not continue to the combination phase. Therefore 201 entered the combination phase.
Primary therapy period:
For Part I (10 day monotherapy): 24-Jan-2005 to 04-May-2005
Part II (Dose Ranging): 14-Jun-2005 to 04-Oct-2006 (48 weeks); 14-Jun-2005 to 12-Jul-2010 (240 weeks)
Multicenter (29) in the United States (14) and Ex-US (15)
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0518 100 mg b.i.d. | Cohort I-Monotherapy Phase MK0518 100 mg twice daily (b.i.d.) Cohort II Combined-Combination Therapy Phase MK0518 100 mg + tenofovir + lamivudine |
| FG001 | MK0518 200 mg b.i.d |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort I-Monotherapy Phase 10 Days |
|
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| 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 |
|
| Comparator: MK0518 combination therapy | Drug | MK0518 twice daily for 48 weeks |
|
| Comparator: efavirenz | Drug | efavirenz 600 mg every night at bedtime 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 |
|
| Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | 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 | 144 Weeks |
| Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | 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. | Week 240 |
| Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay. | Week 240 |
| Baseline and Week 24 |
| Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) | Baseline and Week 24 |
| Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | 96 Weeks |
| Change From Baseline in Plasma HIV RNA at Week 96 | Baseline and Week 96 |
| Change From Baseline in CD4 Cell Count at Week 96 | Baseline and Week 96 |
| Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. | Week 240 |
| Change From Baseline in Plasma HIV RNA at Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. | Baseline and Week 240 |
| Change From Baseline in CD4 (T-helper) Cell Count at Week 240 | Change in number of CD4 cells/mm^3 from baseline to Week 240. | Baseline and Week 240 |
| 48 weeks |
| Number of Patients With Serious Drug-related CAEs | 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. | 48 Weeks |
| Number of Patients That Discontinued With CAEs | 48 Weeks |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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 | 48 Weeks |
| Number of Patients With Serious LAEs | Serious LAEs are any LAEs 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 | 48 Weeks |
| Number of Patients With Drug-related LAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | 48 Weeks |
| Number of Patients With Serious Drug-related LAEs | Serious LAEs are any LAEs 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 | 48 Weeks |
| Number of Patients That Discontinued With LAEs | 48 Weeks |
| Background |
| Murray JM, Emery S, Kelleher AD, Law M, Chen J, Hazuda DJ, Nguyen BY, Teppler H, Cooper DA. Antiretroviral therapy with the integrase inhibitor raltegravir alters decay kinetics of HIV, significantly reducing the second phase. AIDS. 2007 Nov 12;21(17):2315-21. doi: 10.1097/QAD.0b013e3282f12377. |
| 17721395 | Background | Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c. |
| 19648823 | Background | Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Campbell H, Strohmaier KM, Wan H, Danovich RM, Teppler H; Protocol 004 Part II Study Team. Sustained antiretroviral effect of raltegravir after 96 weeks of combination therapy in treatment-naive patients with HIV-1 infection. J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):350-6. doi: 10.1097/QAI.0b013e3181b064b0. |
Cohort I-Monotherapy Phase
MK0518 200 mg b.i.d
Cohort II Combined-Combination Therapy Phase
MK0518 200 mg + tenofovir + lamivudine
| FG002 | MK0518 400 mg b.i.d. | Cohort I-Monotherapy Phase MK0518 400 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 400 mg + tenofovir + lamivudine |
| FG003 | MK0518 600 mg b.i.d. | Cohort I-Monotherapy Phase MK0518 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 600 mg + tenofovir + lamivudine |
| FG004 | Placebo | Cohort I-Monotherapy Phase Placebo to MK0518 b.i.d. |
| FG005 | Efavirenz 600 mg q.h.s. | Cohort II Combined-Combination Therapy Phase efavirenz 600 mg every night at bedtime (q.h.s.) |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
| Cohort I & II-Combination Therapy Phase |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK0518 100 mg b.i.d. | Cohort I-Monotherapy Phase (10 Days) MK0518 100 mg twice daily (b.i.d.) Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d |
| BG001 | MK0518 200 mg b.i.d | Cohort I-Monotherapy Phase (10 Days) MK0518 200 mg b.i.d Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine |
| BG002 | MK0518 400 mg b.i.d. | Cohort I-Monotherapy Phase (10 Days) MK0518 400 mg b.i.d. Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine |
| BG003 | MK0518 600 mg b.i.d. | Cohort I-Monotherapy Phase (10 Days) MK0518 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine |
| BG004 | Placebo / Efavirenz 600 mg Once Daily (q.d.) | Cohort I-Monotherapy Phase (10 Days) Placebo to MK0518 b.i.d. Cohort II Combined-Combination Therapy Phase (48 Weeks) Efavirenz + Tenofovir + Lamivudine |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Cohort I Participants: MK0518 100 mg b.i.d. (7); MK0518 200 mg b.i.d. (7); MK0518 400 mg b.i.d. (6); MK0518 600 mg b.i.d. (8); Placebo Cohort (7) Cohort II Participants: MK0518 100 mg b.i.d. (33); MK0518 200 mg b.i.d. (33); MK0518 400 mg b.i.d. (35); MK0518 600 mg b.i.d. (34); Efavirenz 600 mg q.d. (34) Cohort I & II Participants Combined: MK0518 100 mg b.i.d. (39); MK0518 200 mg b.i.d. (40); MK0518 400 mg b.i.d. (41); MK0518 600 mg b.i.d. (40); Efavirenz 600 mg q.d. (38) | Mean | Full Range | Years |
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| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Cluster of differentiation 4 (CD4) Cell Count | Cohort I Participants: MK0518 100 mg b.i.d. (7); MK0518 200 mg b.i.d. (7); MK0518 400 mg b.i.d. (6); MK0518 600 mg b.i.d. (8); Placebo Cohort (7) Cohort II Participants: MK0518 100 mg b.i.d. (33); MK0518 200 mg b.i.d. (33); MK0518 400 mg b.i.d. (35); MK0518 600 mg b.i.d. (34); Efavirenz 600 mg q.d. (34) Cohort I & II Participants Combined: MK0518 100 mg b.i.d. (39); MK0518 200 mg b.i.d. (40); MK0518 400 mg b.i.d. (41); MK0518 600 mg b.i.d. (40); Efavirenz 600 mg q.d. (38) | Mean | Full Range | cells/mm^3 |
| ||||||||||||||
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) | Cohort I Participants: MK0518 100 mg b.i.d. (7); MK0518 200 mg b.i.d. (7); MK0518 400 mg b.i.d. (6); MK0518 600 mg b.i.d. (8); Placebo Cohort (7) Cohort II Participants: MK0518 100 mg b.i.d. (33); MK0518 200 mg b.i.d. (33); MK0518 400 mg b.i.d. (35); MK0518 600 mg b.i.d. (34); Efavirenz 600 mg q.d. (34) Cohort I & II Participants Combined: MK0518 100 mg b.i.d. (39); MK0518 200 mg b.i.d. (40); MK0518 400 mg b.i.d. (41); MK0518 600 mg b.i.d. (40); Efavirenz 600 mg q.d. (38) | Geometric Mean | Full Range | copies/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) | Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL) | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Mean | 95% Confidence Interval | copies/mL | Baseline and Day 10 |
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| Primary | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) | 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. | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 10 days |
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| Primary | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients who took study medication and had HIV RNA tests performed were included in the analysis. | Posted | Number | participants | Week 24 |
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| Primary | Number of Patients With Clinical Adverse Experiences (CAEs) | 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. | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 weeks |
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| Other Pre-specified | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Number | participants | 48 weeks |
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| Other Pre-specified | Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 weeks |
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| Other Pre-specified | Number of Patients With Serious Drug-related CAEs | 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment. | The analysis population is based upon the All Patients As Treated (APaT) approach | Posted | Number | participants | 48 Weeks |
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| Other Pre-specified | Number of Patients That Discontinued With CAEs | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 Weeks |
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| Other Pre-specified | Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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 | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 Weeks |
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| Other Pre-specified | Number of Patients With Serious LAEs | Serious LAEs are any LAEs 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 | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 Weeks |
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| Other Pre-specified | Number of Patients With Drug-related LAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 Weeks |
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| Other Pre-specified | Number of Patients With Serious Drug-related LAEs | Serious LAEs are any LAEs 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 | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 Weeks |
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| Primary | Number of Patients With Serious CAEs (Cohort I and II Combined) | 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 | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 weeks |
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| Primary | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 | 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 | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 144 Weeks |
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| Secondary | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Number | participants | Week 24 |
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| Primary | Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) | 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. | The analysis population was based upon the All Patients As Treated (APaT) approach. | Posted | Number | Participants | Week 240 |
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| Primary | Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay. | Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses. | Posted | Number | Participants | Week 240 |
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| Secondary | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) | Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL) | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Mean | 95% Confidence Interval | copies/mL | Baseline and Week 24 |
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| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) | Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. | Posted | Mean | 95% Confidence Interval | cells/mm3 | Baseline and Week 24 |
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| Secondary | Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks. | Posted | Number | participants | 96 Weeks |
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| Secondary | Change From Baseline in Plasma HIV RNA at Week 96 | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks. | Posted | Mean | 95% Confidence Interval | copies/mL | Baseline and Week 96 |
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| Secondary | Change From Baseline in CD4 Cell Count at Week 96 | The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks. | Posted | Mean | 95% Confidence Interval | cells/mm3 | Baseline and Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. | Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses. | Posted | Number | Participants | Week 240 |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Plasma HIV RNA at Week 240 | HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. | Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses. | Posted | Mean | 95% Confidence Interval | Log10Copies/mL | Baseline and Week 240 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 (T-helper) Cell Count at Week 240 | Change in number of CD4 cells/mm^3 from baseline to Week 240. | Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline and Week 240 |
|
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients That Discontinued With LAEs | The analysis population is based upon the All Patients As Treated (APaT) approach. | Posted | Number | participants | 48 Weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-0518 b.i.d. | Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine | 25 | 160 | 147 | 160 | ||
| EG001 | Efavirenz | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. | 4 | 38 | 35 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal vein occlusion | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Kaposi's sarcoma AIDS related | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| Adverse Event |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other Reason |
|
| Completed Base Study, Did Not Continue |
|
| Laboratory Adverse Experience |
|
| Cohort II |
|
| Cohort I & II Combined |
|
| Male (Cohort I) |
|
| Female (Cohort II) |
|
| Male (Cohort II) |
|
| Never Treated Cohort II |
|
| Black (Cohort I) |
|
| Asian (Cohort I) |
|
| Hispanic (Cohort I) |
|
| White (Cohort II) |
|
| Black (Cohort II) |
|
| Asian (Cohort II) |
|
| Hispanic (Cohort II) |
|
| Other (Cohort II) |
|
| Never Treated (Cohort II) |
|
| Cohort II |
|
| Cohort I and II Combined |
|
| Cohort II |
|
| Cohort I and II Combined |
|
| MK0518 600 mg b.i.d. |
Cohort I-Monotherapy Phase MK0518 600 mg b.i.d. |
| OG004 | Placebo | Cohort I-Monotherapy Phase Placebo to MK0518 b.i.d. |
|
|
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir + lamivudine |
|
|
Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
| OG003 |
| MK0518 600 mg b.i.d. |
Cohort I-Monotherapy Phase MK0518 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 600 mg + tenofovir + lamivudine |
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
| EFV Combo Therapy |
EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
Cohort I-Monotherapy Phase
MK0518 600 mg b.i.d.
Cohort II Combined-Combination Therapy Phase
MK0518 600 mg + tenofovir + lamivudine
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
Cohort I-Monotherapy Phase MK0518 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 600 mg + tenofovir + lamivudine |
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
Cohort I-Monotherapy Phase MK0518 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 600 mg + tenofovir + lamivudine |
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
Cohort I-Monotherapy Phase MK0518 600 mg b.i.d. Cohort II Combined-Combination Therapy Phase MK0518 600 mg + tenofovir + lamivudine |
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|
| Participants |
|
|
| EFV Combo Therapy |
EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir + lamivudine |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir + lamivudine |
|
|
| OG004 | EFV Combo Therapy | EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir + lamivudine |
|
|
|
|
|
|
|
|
| EFV Combo Therapy |
EFV Combo Therapy Phase - Cohort II efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine This arm included participants from Cohort I who were randomized to placebo. |
|
|