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Completed

NCT Number: NCT00105157

Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
  • Patient must be currently on antiretroviral therapy (ART)

Exclusion criteria

  • Patient less than 18 years of age
  • Additional exclusion criteria will be discussed and identified by the study doctor

Treatment and study plan

Comparator: MK0518

Drug

MK0518 oral tablets 200 mg b.i.d, for 24 weeks

Other names: MK0518

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

Primary outcomes

  1. Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24

    Time frame: Baseline and Week 24

    Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

Secondary outcomes

  1. Number of Patients With Virologic Responses at Week 24

    Time frame: 24 weeks

    Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24

  2. Change From Baseline in CD4 Cell Count at Week 24

    Time frame: Baseline and Week 24

    Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)

  3. Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks

    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 SPONSOR'S product, whether or not considered related to the use of the product

  4. Number of Patients With Serious CAEs at 48 Weeks

    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

  5. Number of Patients With Drug-related CAEs at 48 Weeks

    Time frame: 48 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  6. Number of Patients With Serious Drug-related CAEs at 48 Weeks

    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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

  7. Number of Patients That Died by 48 Weeks

    Time frame: 48 weeks

  8. Number of Patients That Discontinued With CAEs at 48 Weeks

    Time frame: 48 weeks

  9. Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks

    Time frame: 48 weeks

  10. Number of Patients That Discontinued With Serious CAEs at 48 Weeks

    Time frame: 48 weeks

  11. Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks

    Time frame: 48 weeks

  12. Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks

    Time frame: 48 weeks

    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

  13. Number of Patients With Drug-related LAEs at 48 Weeks

    Time frame: 48 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

  14. Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks

    Time frame: 48 weeks

  15. Number of Patients Discontinued With Drug-related LAEs at 48 Weeks

    Time frame: 48 weeks

  16. Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks

    Time frame: 96 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 SPONSOR'S product, whether or not considered related to the use of the product

  17. Number of Patients With Serious CAEs at 96 Weeks

    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

  18. Number of Patients With Drug-related CAEs at 96 Weeks

    Time frame: 96 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  19. Number of Patients With Serious Drug-related CAEs at 96 Weeks

    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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

  20. Number of Patients That Died by 96 Weeks

    Time frame: 96 weeks

  21. Number of Patients That Discontinued With CAEs at 96 Weeks

    Time frame: 96 weeks

  22. Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks

    Time frame: 96 weeks

  23. Number of Patients That Discontinued With Serious CAEs at 96 Weeks

    Time frame: 96 weeks

  24. Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks

    Time frame: 96 weeks

  25. Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks

    Time frame: 96 weeks

    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

  26. Number of Patients With Drug-related LAEs at 96 Weeks

    Time frame: 96 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

  27. Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks

    Time frame: 96 weeks

  28. Number of Patients Discontinued With Drug-related LAEs at 96 Weeks

    Time frame: 96 weeks

  29. Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks

    Time frame: 168 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 SPONSOR'S product, whether or not considered related to the use of the product

  30. Number of Patients With Serious CAEs at 168 Weeks

    Time frame: 168 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

  31. Number of Patients With Drug-related CAEs at 168 Weeks

    Time frame: 168 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  32. Number of Patients With Serious Drug-related CAEs at 168 Weeks

    Time frame: 168 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

  33. Number of Patients That Died by 168 Weeks

    Time frame: 168 weeks

  34. Number of Patients That Discontinued With CAEs at 168 Weeks

    Time frame: 168 weeks

  35. Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks

    Time frame: 168 weeks

  36. Number of Patients That Discontinued With Serious CAEs at 168 Weeks

    Time frame: 168 weeks

  37. Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks

    Time frame: 168 weeks

  38. Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks

    Time frame: 168 weeks

    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

  39. Number of Patients With Serious LAEs at 168 Weeks

    Time frame: 168 weeks

    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

  40. Number of Patients Discontinued With Drug-related LAEs at 168 Weeks

    Time frame: 168 weeks

  41. Number of Patients With Drug-related LAEs at 168 Weeks

    Time frame: 168 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

  42. Number of Patients With Serious Drug-related LAEs at 168 Weeks

    Time frame: 168 weeks

    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

  43. Number of Patients Discontinued With LAEs at 168 Weeks

    Time frame: 168 weeks

Other outcomes

  1. Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies

    Time frame: Baseline and Week 168

    Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.

  2. Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies

    Time frame: Baseline and Week 168

    Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance

Important dates

Study start
2005
Primary completion
2006
Study completion
2009
First posted
Mar 9, 2005
Registry last updated
Dec 4, 2015

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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