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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00105157
First received: March 8, 2005
Last updated: November 27, 2013
Last verified: November 2013
Results First Received: September 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Interventions: Drug: Comparator: MK0518
Drug: MK0518
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK0518 200 mg b.i.d. Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
MK0518 400 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
MK0518 600 mg b.i.d. OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Placebo OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
Total Total of all reporting groups

Baseline Measures
    MK0518 200 mg b.i.d.     MK0518 400 mg b.i.d.     MK0518 600 mg b.i.d.     Placebo     Total  
Number of Participants  
[units: participants]
  43     45     45     45     178  
Age  
[units: years]
Mean ( Full Range )
  44.0  
  ( 18 to 57 )  
  45.1  
  ( 32 to 69 )  
  43.8  
  ( 25 to 63 )  
  43.3  
  ( 29 to 59 )  
  44.1  
  ( 18 to 69 )  
Gender  
[units: participants]
         
Female     7     5     4     5     21  
Male     36     40     41     40     157  
Race/Ethnicity, Customized  
[units: participants]
         
White     36     35     32     33     136  
Black     3     5     7     5     20  
Asian     0     0     2     1     3  
Hispanic     4     5     4     5     18  
Others     0     0     0     1     1  
Cluster of Differentiation 4 (CD4) Cell Count  
[units: Cells/mm3]
Mean ( Full Range )
  244.9  
  ( 30 to 1153 )  
  220.6  
  ( 68 to 673 )  
  220.4  
  ( 30 to 663 )  
  274.0  
  ( 37 to 880 )  
  239.9  
  ( 30 to 1153 )  
Plasma HIV RNA  
[units: log10┬ácopies/mL]
Mean ( Full Range )
  4.6  
  ( 3.5 to 5.9 )  
  4.8  
  ( 3.7 to 5.9 )  
  4.7  
  ( 3.8 to 5.8 )  
  4.7  
  ( 3.6 to 5.8 )  
  4.7  
  ( 3.5 to 5.9 )  
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)  
[units: Copies/mL]
Mean ( Full Range )
  44642.6  
  ( 3000 to 750000 )  
  59107.9  
  ( 4770 to 750000 )  
  49064.8  
  ( 7030 to 589000 )  
  47432.6  
  ( 3630 to 611000 )  
  49841.6  
  ( 3000 to 750000 )  



  Outcome Measures
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1.  Primary:   Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Number of Patients With Virologic Responses at Week 24   [ Time Frame: 24 weeks ]

3.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks   [ Time Frame: 48 weeks ]

5.  Secondary:   Number of Patients With Serious CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

6.  Secondary:   Number of Patients With Drug-related CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

7.  Secondary:   Number of Patients With Serious Drug-related CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

8.  Secondary:   Number of Patients That Died by 48 Weeks   [ Time Frame: 48 weeks ]

9.  Secondary:   Number of Patients That Discontinued With CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

10.  Secondary:   Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

11.  Secondary:   Number of Patients That Discontinued With Serious CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

12.  Secondary:   Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks   [ Time Frame: 48 weeks ]

13.  Secondary:   Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks   [ Time Frame: 48 weeks ]

14.  Secondary:   Number of Patients With Drug-related LAEs at 48 Weeks   [ Time Frame: 48 weeks ]

15.  Secondary:   Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks   [ Time Frame: 48 weeks ]

16.  Secondary:   Number of Patients Discontinued With Drug-related LAEs at 48 Weeks   [ Time Frame: 48 weeks ]

17.  Secondary:   Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks   [ Time Frame: 96 weeks ]

18.  Secondary:   Number of Patients With Serious CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

19.  Secondary:   Number of Patients With Drug-related CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

20.  Secondary:   Number of Patients With Serious Drug-related CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

21.  Secondary:   Number of Patients That Died by 96 Weeks   [ Time Frame: 96 weeks ]

22.  Secondary:   Number of Patients That Discontinued With CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

23.  Secondary:   Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

24.  Secondary:   Number of Patients That Discontinued With Serious CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

25.  Secondary:   Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks   [ Time Frame: 96 weeks ]

26.  Secondary:   Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks   [ Time Frame: 96 weeks ]

27.  Secondary:   Number of Patients With Drug-related LAEs at 96 Weeks   [ Time Frame: 96 weeks ]

28.  Secondary:   Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks   [ Time Frame: 96 weeks ]

29.  Secondary:   Number of Patients Discontinued With Drug-related LAEs at 96 Weeks   [ Time Frame: 96 weeks ]

30.  Secondary:   Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks   [ Time Frame: 168 weeks ]

31.  Secondary:   Number of Patients With Serious CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

32.  Secondary:   Number of Patients With Drug-related CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

33.  Secondary:   Number of Patients With Serious Drug-related CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

34.  Secondary:   Number of Patients That Died by 168 Weeks   [ Time Frame: 168 weeks ]

35.  Secondary:   Number of Patients That Discontinued With CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

36.  Secondary:   Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

37.  Secondary:   Number of Patients That Discontinued With Serious CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

38.  Secondary:   Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks   [ Time Frame: 168 weeks ]

39.  Secondary:   Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks   [ Time Frame: 168 weeks ]

40.  Secondary:   Number of Patients With Serious LAEs at 168 Weeks   [ Time Frame: 168 weeks ]

41.  Secondary:   Number of Patients Discontinued With Drug-related LAEs at 168 Weeks   [ Time Frame: 168 weeks ]

42.  Secondary:   Number of Patients With Drug-related LAEs at 168 Weeks   [ Time Frame: 168 weeks ]

43.  Secondary:   Number of Patients With Serious Drug-related LAEs at 168 Weeks   [ Time Frame: 168 weeks ]

44.  Secondary:   Number of Patients Discontinued With LAEs at 168 Weeks   [ Time Frame: 168 weeks ]

45.  Post-Hoc:   Number of Patients With Virologic Responses at Week 168 in Combined Substudies   [ Time Frame: 168 weeks ]

46.  Other Pre-specified:   Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies   [ Time Frame: Baseline and Week 168 ]

47.  Other Pre-specified:   Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies   [ Time Frame: Baseline and Week 168 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to a 3:1 randomization of MK-0518 to placebo and more discontinuations for placebo in the doubleblind phase, exposure for MK-0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.


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