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OpenTrials
Completed

NCT Number: 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)

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 past
  • Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
  • Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
  • Participant has used another experimental HIV-integrase inhibitor
  • Participant has a current (active) diagnosis of acute hepatitis due to any cause
  • Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests

Treatment and study plan

MK-0518

Drug

400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks

Other names: raltegravir, Isentress®

Comparator: efavirenz

Drug

600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks

Other names: Sustiva®

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)

Other names: emtricitabine/tenofovir disoproxil fumarate

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

Primary outcomes

  1. Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

    Time frame: 48 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.

  2. Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48

    Time frame: 48 Weeks

    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.

  3. Number of Participants With Serious CAEs at Week 48

    Time frame: 48 Weeks

    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.

  4. Number of Participants With Drug-related CAEs at Week 48

    Time frame: 48 Weeks

    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.

  5. Number of Participants With Serious Drug-related CAEs at Week 48

    Time frame: 48 Weeks

    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.

  6. Number of Participants That Died by Week 48

    Time frame: 48 Weeks

    All participant deaths in the span of 48 weeks on study were recorded.

  7. Number of Participants That Discontinued With CAEs at Week 48

    Time frame: 48 Weeks

    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.

  8. Number of Participants That Discontinued With Serious CAEs at Week 48

    Time frame: 48 Weeks

    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.

  9. Number of Participants That Discontinued With Drug-related CAEs at Week 48

    Time frame: 48 Weeks

    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.

  10. Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48

    Time frame: 48 Weeks

    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.

  11. Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48

    Time frame: 48 Weeks

    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.

  12. Number of Participants With Serious LAEs at Week 48

    Time frame: 48 Weeks

    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.

  13. Number of Participants With Drug-related LAEs at Week 48

    Time frame: 48 Weeks

    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.

  14. Number of Participants With Serious Drug-related LAEs at Week 48

    Time frame: 48 Weeks

    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.

  15. Number of Participants Discontinued With LAEs at Week 48

    Time frame: 48 Weeks

    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.

  16. Number of Participants Discontinued With Drug-related LAEs at Week 48

    Time frame: 48 Weeks

    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.

Secondary outcomes

  1. Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48

    Time frame: 48 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.

  2. Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48

    Time frame: Baseline and Week 48

    Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)

  3. Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96

    Time frame: 96 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.

  4. Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96

    Time frame: 96 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.

  5. Change From Baseline in CD4 Cell Count at Week 96

    Time frame: Baseline and Week 96

    Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)

  6. Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156

    Time frame: 156 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.

  7. Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156

    Time frame: 156 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.

  8. Change From Baseline in CD4 Cell Count at Week 156

    Time frame: Baseline and Week 156

    Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)

  9. Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240

    Time frame: 240 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.

  10. Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240

    Time frame: 240 Weeks

    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.

  11. Change From Baseline in CD4 Cell Count at Week 240

    Time frame: Baseline and Week 240

    Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)

  12. Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8

    Time frame: 8 Weeks

    Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression

  13. Number of Participants With CAEs at Week 96

    Time frame: 96 Weeks

    An adverse event (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.

  14. Number of Participants With CAEs at Week 156

    Time frame: 156 Weeks

    An adverse event (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.

  15. Number of Participants With CAEs at Week 240

    Time frame: 240 Weeks

    An adverse event (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.

  16. Number of Participants With Serious CAEs at Week 96

    Time frame: 96 Weeks

    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.

  17. Number of Participants With Serious CAEs at Week 156

    Time frame: 156 Weeks

    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.

  18. Number of Participants With Serious CAEs at Week 240

    Time frame: 240 Weeks

    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.

  19. Number of Participants With Drug-related CAEs at Week 96

    Time frame: 96 Weeks

    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.

  20. Number of Participants With Drug-related CAEs at Week 156

    Time frame: 156 Weeks

    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.

  21. Number of Participants With Drug-related CAEs at Week 240

    Time frame: 240 Weeks

    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.

  22. Number of Participants With Serious Drug-related CAEs at Week 96

    Time frame: 96 Weeks

    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.

  23. Number of Participants With Serious Drug-related CAEs at Week 156

    Time frame: 156 Weeks

    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.

  24. Number of Participants With Serious Drug-related CAEs at Week 240

    Time frame: 240 Weeks

    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.

  25. Number of Participants That Died by Week 96

    Time frame: 96 Weeks

    All participant deaths in the span of 96 weeks on study were recorded.

  26. Number of Participants That Died by Week 156

    Time frame: 156 Weeks

    All participant deaths in the span of 156 weeks on study were recorded.

  27. Number of Participants That Died by Week 240

    Time frame: 240 Weeks

    All participant deaths in the span of 240 weeks on study were recorded.

  28. Number of Participants That Discontinued With CAEs at Week 96

    Time frame: 96 Weeks

    An adverse event (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.

  29. Number of Participants That Discontinued With CAEs at Week 156

    Time frame: 156 Weeks

    An adverse event (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.

  30. Number of Participants That Discontinued With CAEs at Week 240

    Time frame: 240 Weeks

    An adverse event (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.

  31. Number of Participants That Discontinued With Drug-related CAEs at Week 96

    Time frame: 96 Weeks

    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.

  32. Number of Participants That Discontinued With Drug-related CAEs at Week 156

    Time frame: 156 Weeks

    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.

  33. Number of Participants That Discontinued With Drug-related CAEs at Week 240

    Time frame: 240 Weeks

    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.

  34. Number of Participants That Discontinued With Serious CAEs at Week 96

    Time frame: 96 Weeks

    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.

  35. Number of Participants That Discontinued With Serious CAEs at Week 156

    Time frame: 156 Weeks

    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.

  36. Number of Participants That Discontinued With Serious CAEs at Week 240

    Time frame: 240 Weeks

    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.

  37. Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96

    Time frame: 96 Weeks

    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.

  38. Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156

    Time frame: 156 Weeks

    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.

  39. Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240

    Time frame: 240 Weeks

    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.

  40. Number of Participants With LAEs at Week 96

    Time frame: 96 Weeks

    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.

  41. Number of Participants With LAEs at Week 156

    Time frame: 156 Weeks

    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.

  42. Number of Participants With LAEs at Week 240

    Time frame: 240 Weeks

    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.

  43. Number of Participants With Drug-related LAEs at Week 96

    Time frame: 96 Weeks

    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.

  44. Number of Participants With Drug-related LAEs at Week 156

    Time frame: 156 Weeks

    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.

  45. Number of Participants With Drug-related LAEs at Week 240

    Time frame: 240 Weeks

    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.

  46. Number of Participants With Serious LAEs at Week 96

    Time frame: 96 Weeks

    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.

  47. Number of Participants With Serious LAEs at Week 156

    Time frame: 156 Weeks

    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.

  48. Number of Participants With Serious LAEs at Week 240

    Time frame: 240 Weeks

    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.

  49. Number of Participants With Serious Drug-related LAEs at Week 96

    Time frame: 96 Weeks

    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.

  50. Number of Participants With Serious Drug-related LAEs at Week 156

    Time frame: 156 Weeks

    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.

  51. Number of Participants With Serious Drug-related LAEs at Week 240

    Time frame: 240 Weeks

    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.

  52. Number of Participants Discontinued With LAEs at Week 96

    Time frame: 96 Weeks

    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.

  53. Number of Participants Discontinued With LAEs at Week 156

    Time frame: 156 Weeks

    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.

  54. Number of Participants Discontinued With LAEs at Week 240

    Time frame: 240 Weeks

    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.

  55. Number of Participants Discontinued With Drug-related LAEs at Week 96

    Time frame: 96 Weeks

    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.

  56. Number of Participants Discontinued With Drug-related LAEs at Week 156

    Time frame: 156 Weeks

    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.

  57. Number of Participants Discontinued With Drug-related LAEs at Week 240

    Time frame: 240 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™

Important dates

Study start
2006
Primary completion
2009
Study completion
2012
First posted
Aug 30, 2006
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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