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A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00293267
Collaborator
(none)
352
Enrollment
2
Arms
62.9
Duration (Months)

Study Details

Study Description

Brief Summary

This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.

Condition or Disease Intervention/Treatment Phase
  • Drug: raltegravir potassium
  • Drug: Comparator: Placebo
 Phase 3

Detailed Description

The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Study Design

Study Type:
Interventional
Actual Enrollment :
352 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiviral Therapies
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

raltegravir potassium

Drug: raltegravir potassium
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Other Names:
  • ISENTRESS™

    		•
    Placebo Comparator: 2

    Placebo

    Drug: Comparator: Placebo
    Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16 [16 Weeks]

      Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16

    2. Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48 [48 Weeks]

      Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48

    3. Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL [156 Weeks]

      Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156

    4. Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL [240 Weeks]

      Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240

    Secondary Outcome Measures

    1. Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16 [16 Weeks]

      Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16

    2. Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48 [48 Weeks]

      Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48

    3. Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL [156 weeks]

      Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156

    4. Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL [240 weeks]

      Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240

    5. Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response [156 weeks]

      For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).

    6. Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16 [Baseline and Week 16]

      Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)

    7. Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48 [Baseline and Week 48]

      Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)

    8. Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL) [Baseline and Week 156]

      Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)

    9. Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL) [Baseline and Week 240]

      Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)

    10. Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16 [Baseline and Week 16]

      Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)

    11. Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 [Baseline and Week 48]

      Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)

    12. Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3) [Baseline and Week 156]

      Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)

    13. Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3) [Baseline and Week 240]

      Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient must be HIV positive with HIV RNA values that are within ranges required by the study

    • Patient must have documented failure of certain antiretroviral therapy

    • Patient must be on the same antiretroviral therapy for at least the past two months

    Exclusion Criteria:

    • Patient is less than 16 years old

    • Additional study criteria will be discussed and identified by the study doctor

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00293267
    Other Study ID Numbers:
    • 0518-018
    • 2005_096
    First Posted:
    Feb 17, 2006
    Last Update Posted:
    Sep 7, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Merck Sharp & Dohme LLC
    Treatment Experienced
    Additional relevant MeSH terms:
    HIV Infections
    Raltegravir Potassium

    Study Results

    Participant Flow

    Recruitment Details Phase 3; First Patient In: Mar 2006; Last Patient Last Visit (LPLV) Week 48: Aug 2007; 61 of 63 sites in Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, Thailand randomized patients. Extension Study LPLV Week 240: June 2011
    Pre-assignment Detail Patients failed prior antiretroviral therapy (HIV RNA >1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Period Title: Primary Study - Double-Blind Week 0-48
    STARTED 234 118
    Treated 232 118
    Continuing in Double-Blind 193 50
    COMPLETED 193 50
    NOT COMPLETED 41 68
    Period Title: Primary Study - Double-Blind Week 0-48
    STARTED 191 50
    COMPLETED 139 35
    NOT COMPLETED 52 15
    Period Title: Primary Study - Double-Blind Week 0-48
    STARTED 131 28
    COMPLETED 111 26
    NOT COMPLETED 20 2
    Period Title: Primary Study - Double-Blind Week 0-48
    STARTED 48 66
    COMPLETED 15 29
    NOT COMPLETED 33 37

    Baseline Characteristics

    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT Total
    Arm/Group Description Total of all reporting groups
    Overall Participants 232 118 350
    Age (Years) [Mean (Full Range) ]
    Mean (Full Range) [Years]
    46.1
    43.7
    45.3
    Sex: Female, Male (Count of Participants)
    Female
    37
    15.9%
    15
    12.7%
    52
    14.9%
    Male
    195
    84.1%
    103
    87.3%
    298
    85.1%
    Race/Ethnicity, Customized (participants) [Number]
    White
    174
    75%
    96
    81.4%
    270
    77.1%
    Black
    18
    7.8%
    5
    4.2%
    23
    6.6%
    Asian
    14
    6%
    5
    4.2%
    19
    5.4%
    Hispanic
    6
    2.6%
    1
    0.8%
    7
    2%
    Other
    20
    8.6%
    11
    9.3%
    31
    8.9%
    Cluster of Differentiation 4 (CD4) Cell Count (cells/mm^3) [Mean (Full Range) ]
    Mean (Full Range) [cells/mm^3]
    156
    153
    155
    Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) (copies/mL) [Geometric Mean (Full Range) ]
    Geometric Mean (Full Range) [copies/mL]
    40519
    31828
    37352

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
    Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
    Time Frame 16 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 229 117
    Number (95% Confidence Interval) [Percentage of Participants]
    77.7
    33.5%
    41.0
    34.7%
    2. Secondary Outcome
    Title Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
    Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
    Time Frame 16 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 229 117
    Number (95% Confidence Interval) [Percentage of Participants]
    61.6
    26.6%
    33.3
    28.2%
    3. Secondary Outcome
    Title Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
    Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
    Time Frame 48 Weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 231 118
    Number (95% Confidence Interval) [Percentage of Participants]
    64.5
    27.8%
    31.4
    26.6%
    4. Secondary Outcome
    Title Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
    Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
    Time Frame 156 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 232 117
    Number (95% Confidence Interval) [Percentage of Participants]
    53.4
    23%
    25.6
    21.7%
    5. Secondary Outcome
    Title Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
    Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
    Time Frame 240 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240. Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
    Measure Participants 232 118
    Number (95% Confidence Interval) [Percentage of Participants]
    42.2
    18.2%
    18.6
    15.8%
    6. Primary Outcome
    Title Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
    Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
    Time Frame 48 Weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 231 118
    Number (95% Confidence Interval) [Percentage of Participants]
    73.6
    31.7%
    36.4
    30.8%
    7. Secondary Outcome
    Title Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
    Description For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).
    Time Frame 156 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 232 118
    Number [Percentage of Participants]
    47.4
    20.4%
    24.6
    20.8%
    8. Secondary Outcome
    Title Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16
    Description Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)
    Time Frame Baseline and Week 16

    Outcome Measure Data

    Analysis Population Description
    Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry- forward for all failures/discontinued due to lack of efficacy
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 231 118
    Mean (95% Confidence Interval) [HIV RNA (log10 copies/mL)]
    -1.85
    -0.78
    9. Secondary Outcome
    Title Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
    Description Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
    Time Frame Baseline and Week 48

    Outcome Measure Data

    Analysis Population Description
    Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy Participants with virologic failure after Week 16 = treatment failures
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 231 118
    Mean (95% Confidence Interval) [HIV RNA (log10 copies/mL)]
    -1.67
    -0.68
    10. Secondary Outcome
    Title Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
    Description Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
    Time Frame Baseline and Week 156

    Outcome Measure Data

    Analysis Population Description
    Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy Participants with virologic failure after Week 16 = treatment failures
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 207 107
    Mean (95% Confidence Interval) [HIV RNA (log10 copies/mL)]
    -1.44
    -0.51
    11. Secondary Outcome
    Title Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
    Description Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
    Time Frame Baseline and Week 240

    Outcome Measure Data

    Analysis Population Description
    Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy Participants with virologic failure after Week 16 = treatment failures
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240. Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
    Measure Participants 188 100
    Mean (95% Confidence Interval) [HIV RNA (log10 copies/mL)]
    -1.24
    -0.45
    12. Primary Outcome
    Title Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
    Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
    Time Frame 156 Weeks

    Outcome Measure Data

    Analysis Population Description
    The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures. Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 232 117
    Number (95% Confidence Interval) [Percentage of Participants]
    57.3
    24.7%
    25.6
    21.7%
    13. Secondary Outcome
    Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
    Description Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)
    Time Frame Baseline and Week 16

    Outcome Measure Data

    Analysis Population Description
    Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 231 118
    Mean (95% Confidence Interval) [CD4 Cell Count (cells/mm^3)]
    82.7
    31.3
    14. Secondary Outcome
    Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
    Description Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)
    Time Frame Baseline and Week 48

    Outcome Measure Data

    Analysis Population Description
    Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy. Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 230 119
    Mean (95% Confidence Interval) [CD4 Cell Count (cells/mm^3)]
    120.2
    49.4
    15. Primary Outcome
    Title Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
    Description Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
    Time Frame 240 Weeks

    Outcome Measure Data

    Analysis Population Description
    The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures. Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240. Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
    Measure Participants 232 118
    Number (95% Confidence Interval) [Percentage of Participants]
    45.3
    19.5%
    20.3
    17.2%
    16. Secondary Outcome
    Title Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)
    Description Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)
    Time Frame Baseline and Week 156

    Outcome Measure Data

    Analysis Population Description
    Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy. Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description
    Measure Participants 207 107
    Mean (95% Confidence Interval) [CD4 Cell Count (cells/mm^3)]
    170.9
    71.03
    17. Secondary Outcome
    Title Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
    Description Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)
    Time Frame Baseline and Week 240

    Outcome Measure Data

    Analysis Population Description
    Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy. Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.
    Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
    Arm/Group Description Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240. Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
    Measure Participants 186 101
    Mean (95% Confidence Interval) [CD4 Cell Count (cells/mm^3)]
    193.6
    68.2

    Adverse Events

    Time Frame 240 Weeks
    Adverse Event Reporting Description Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
    Arm/Group Title Raltegravir 400 mg b.i.d Plus OBT Placebo Plus OBT
    Arm/Group Description Includes all participants initially randomized to raltegravir, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT. Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
    All Cause Mortality
    Raltegravir 400 mg b.i.d Plus OBT Placebo Plus OBT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Raltegravir 400 mg b.i.d Plus OBT Placebo Plus OBT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 97/232 (41.8%) 46/118 (39%)
    Blood and lymphatic system disorders
    Anaemia 2/232 (0.9%) 2 0/118 (0%) 0
    Haemolytic anaemia 1/232 (0.4%) 1 0/118 (0%) 0
    Haemolytic uraemic syndrome 1/232 (0.4%) 1 0/118 (0%) 0
    Leukopenia 0/232 (0%) 0 1/118 (0.8%) 2
    Neutropenia 0/232 (0%) 0 1/118 (0.8%) 1
    Splenic vein thrombosis 1/232 (0.4%) 1 0/118 (0%) 0
    Cardiac disorders
    Acute coronary syndrome 2/232 (0.9%) 2 0/118 (0%) 0
    Acute myocardial infarction 1/232 (0.4%) 1 0/118 (0%) 0
    Angina pectoris 1/232 (0.4%) 1 0/118 (0%) 0
    Angina unstable 1/232 (0.4%) 1 0/118 (0%) 0
    Cardiac arrest 1/232 (0.4%) 1 0/118 (0%) 0
    Cardio-respiratory arrest 0/232 (0%) 0 1/118 (0.8%) 1
    Coronary artery disease 1/232 (0.4%) 1 1/118 (0.8%) 1
    Intracardiac thrombus 1/232 (0.4%) 1 0/118 (0%) 0
    Myocardial infarction 4/232 (1.7%) 5 2/118 (1.7%) 3
    Pericarditis 1/232 (0.4%) 1 0/118 (0%) 0
    Congenital, familial and genetic disorders
    Phimosis 1/232 (0.4%) 1 0/118 (0%) 0
    Ear and labyrinth disorders
    Hypoacusis 0/232 (0%) 0 1/118 (0.8%) 1
    Vertigo 0/232 (0%) 0 1/118 (0.8%) 1
    Endocrine disorders
    Hyperthyroidism 1/232 (0.4%) 1 0/118 (0%) 0
    Myxoedema 1/232 (0.4%) 1 0/118 (0%) 0
    Eye disorders
    Uveitis 0/232 (0%) 0 1/118 (0.8%) 1
    Gastrointestinal disorders
    Abdominal pain 2/232 (0.9%) 2 0/118 (0%) 0
    Anal fissure 1/232 (0.4%) 1 0/118 (0%) 0
    Ascites 2/232 (0.9%) 2 0/118 (0%) 0
    Constipation 1/232 (0.4%) 1 0/118 (0%) 0
    Diarrhoea 3/232 (1.3%) 4 0/118 (0%) 0
    Enteritis 1/232 (0.4%) 1 0/118 (0%) 0
    Gastric varices 1/232 (0.4%) 1 0/118 (0%) 0
    Gastritis 1/232 (0.4%) 2 0/118 (0%) 0
    Haemorrhoids 1/232 (0.4%) 1 0/118 (0%) 0
    Hernial eventration 1/232 (0.4%) 1 0/118 (0%) 0
    Inguinal hernia 1/232 (0.4%) 1 0/118 (0%) 0
    Intestinal obstruction 1/232 (0.4%) 1 0/118 (0%) 0
    Intestinal perforation 0/232 (0%) 0 1/118 (0.8%) 1
    Mesenteric vein thrombosis 1/232 (0.4%) 1 0/118 (0%) 0
    Oesophagitis 1/232 (0.4%) 1 0/118 (0%) 0
    Rectal haemorrhage 2/232 (0.9%) 2 1/118 (0.8%) 1
    Rectal perforation 0/232 (0%) 0 1/118 (0.8%) 1
    Rectal stenosis 0/232 (0%) 0 1/118 (0.8%) 1
    Umbilical hernia 0/232 (0%) 0 1/118 (0.8%) 1
    Upper gastrointestinal haemorrhage 1/232 (0.4%) 1 0/118 (0%) 0
    Varices oesophageal 2/232 (0.9%) 2 0/118 (0%) 0
    General disorders
    Asthenia 2/232 (0.9%) 2 1/118 (0.8%) 1
    Chest pain 1/232 (0.4%) 1 0/118 (0%) 0
    Malaise 1/232 (0.4%) 1 0/118 (0%) 0
    Multi-organ failure 1/232 (0.4%) 1 0/118 (0%) 0
    Oedema peripheral 1/232 (0.4%) 1 0/118 (0%) 0
    Pyrexia 3/232 (1.3%) 3 3/118 (2.5%) 11
    Soft tissue inflammation 0/232 (0%) 0 1/118 (0.8%) 1
    Hepatobiliary disorders
    Cholangitis 1/232 (0.4%) 1 0/118 (0%) 0
    Gallbladder disorder 0/232 (0%) 0 1/118 (0.8%) 1
    Hepatitis 2/232 (0.9%) 3 0/118 (0%) 0
    Hepatitis toxic 0/232 (0%) 0 1/118 (0.8%) 1
    Portal hypertension 2/232 (0.9%) 2 0/118 (0%) 0
    Portal vein thrombosis 1/232 (0.4%) 1 0/118 (0%) 0
    Immune system disorders
    Drug hypersensitivity 1/232 (0.4%) 1 0/118 (0%) 0
    Hypersensitivity 1/232 (0.4%) 2 0/118 (0%) 0
    Infections and infestations
    Anogenital warts 2/232 (0.9%) 2 0/118 (0%) 0
    Appendicitis 2/232 (0.9%) 2 0/118 (0%) 0
    Bone tuberculosis 0/232 (0%) 0 1/118 (0.8%) 1
    Bronchopneumonia 2/232 (0.9%) 2 0/118 (0%) 0
    Candidiasis 0/232 (0%) 0 1/118 (0.8%) 1
    Carbuncle 1/232 (0.4%) 1 0/118 (0%) 0
    Cellulitis 2/232 (0.9%) 2 0/118 (0%) 0
    Choriomeningitis lymphocytic 2/232 (0.9%) 2 0/118 (0%) 0
    Cytomegalovirus chorioretinitis 0/232 (0%) 0 1/118 (0.8%) 1
    Cytomegalovirus colitis 0/232 (0%) 0 1/118 (0.8%) 1
    Cytomegalovirus hepatitis 1/232 (0.4%) 1 0/118 (0%) 0
    Cytomegalovirus infection 1/232 (0.4%) 1 0/118 (0%) 0
    Diarrhoea infectious 1/232 (0.4%) 1 0/118 (0%) 0
    Disseminated cytomegaloviral infection 0/232 (0%) 0 1/118 (0.8%) 1
    Dysentery 0/232 (0%) 0 1/118 (0.8%) 1
    End stage AIDS 1/232 (0.4%) 1 1/118 (0.8%) 1
    Endophthalmitis 1/232 (0.4%) 2 0/118 (0%) 0
    Epidermodysplasia verruciformis 0/232 (0%) 0 1/118 (0.8%) 1
    Erythema infectiosum 0/232 (0%) 0 1/118 (0.8%) 1
    Fallopian tube abscess 1/232 (0.4%) 1 0/118 (0%) 0
    Gastroenteritis 1/232 (0.4%) 1 0/118 (0%) 0
    Gastroenteritis viral 1/232 (0.4%) 1 0/118 (0%) 0
    Genital herpes 3/232 (1.3%) 3 0/118 (0%) 0
    Giardiasis 0/232 (0%) 0 1/118 (0.8%) 1
    HIV infection 1/232 (0.4%) 1 0/118 (0%) 0
    Influenza 1/232 (0.4%) 1 0/118 (0%) 0
    Leishmaniasis 0/232 (0%) 0 1/118 (0.8%) 4
    Lower respiratory tract infection 0/232 (0%) 0 1/118 (0.8%) 1
    Meningitis 1/232 (0.4%) 1 0/118 (0%) 0
    Meningitis cryptococcal 1/232 (0.4%) 1 0/118 (0%) 0
    Mycobacterial infection 2/232 (0.9%) 2 0/118 (0%) 0
    Mycobacterium avium complex infection 0/232 (0%) 0 1/118 (0.8%) 1
    Oesophageal candidiasis 1/232 (0.4%) 1 3/118 (2.5%) 3
    Oral candidiasis 0/232 (0%) 0 1/118 (0.8%) 1
    Pharyngitis 1/232 (0.4%) 1 0/118 (0%) 0
    Pneumocystis jiroveci pneumonia 2/232 (0.9%) 2 0/118 (0%) 0
    Pneumonia 11/232 (4.7%) 11 5/118 (4.2%) 6
    Pneumonia fungal 0/232 (0%) 0 1/118 (0.8%) 1
    Pneumonia pneumococcal 1/232 (0.4%) 1 0/118 (0%) 0
    Progressive multifocal leukoencephalopathy 0/232 (0%) 0 1/118 (0.8%) 1
    Pseudomonal sepsis 0/232 (0%) 0 1/118 (0.8%) 1
    Respiratory tract infection 1/232 (0.4%) 1 0/118 (0%) 0
    Sepsis 1/232 (0.4%) 1 0/118 (0%) 0
    Septic shock 2/232 (0.9%) 3 1/118 (0.8%) 2
    Sinusitis 1/232 (0.4%) 1 0/118 (0%) 0
    Staphylococcal bacteraemia 1/232 (0.4%) 1 0/118 (0%) 0
    Subcutaneous abscess 0/232 (0%) 0 1/118 (0.8%) 1
    Syphilis 1/232 (0.4%) 1 1/118 (0.8%) 1
    Tuberculosis of genitourinary system 0/232 (0%) 0 1/118 (0.8%) 1
    Urinary tract infection 0/232 (0%) 0 1/118 (0.8%) 1
    Urosepsis 0/232 (0%) 0 1/118 (0.8%) 1
    Varicella 0/232 (0%) 0 1/118 (0.8%) 1
    Visceral leishmaniasis 0/232 (0%) 0 1/118 (0.8%) 1
    Injury, poisoning and procedural complications
    Accidental overdose 0/232 (0%) 0 1/118 (0.8%) 1
    Fibula fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Foot fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Humerus fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Incisional hernia 1/232 (0.4%) 1 0/118 (0%) 0
    Inflammation of wound 1/232 (0.4%) 1 0/118 (0%) 0
    Intentional overdose 0/232 (0%) 0 1/118 (0.8%) 1
    Jaw fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Lower limb fracture 2/232 (0.9%) 2 0/118 (0%) 0
    Overdose 1/232 (0.4%) 1 2/118 (1.7%) 2
    Post procedural haematuria 1/232 (0.4%) 1 0/118 (0%) 0
    Skull fracture 0/232 (0%) 0 1/118 (0.8%) 1
    Spinal fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Subdural haematoma 1/232 (0.4%) 1 0/118 (0%) 0
    Tendon rupture 2/232 (0.9%) 2 0/118 (0%) 0
    Thoracic vertebral fracture 0/232 (0%) 0 1/118 (0.8%) 3
    Tibia fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Toxicity to various agents 1/232 (0.4%) 1 0/118 (0%) 0
    Wrist fracture 1/232 (0.4%) 1 0/118 (0%) 0
    Investigations
    Alanine aminotransferase increased 2/232 (0.9%) 2 0/118 (0%) 0
    Aspartate aminotransferase increased 2/232 (0.9%) 2 0/118 (0%) 0
    Blood potassium decreased 1/232 (0.4%) 1 0/118 (0%) 0
    Neutrophil count decreased 1/232 (0.4%) 3 0/118 (0%) 0
    Weight decreased 1/232 (0.4%) 1 0/118 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus 1/232 (0.4%) 2 1/118 (0.8%) 1
    Diabetic complication 1/232 (0.4%) 1 0/118 (0%) 0
    Diabetic foot 1/232 (0.4%) 2 0/118 (0%) 0
    Hypoglycaemia 0/232 (0%) 0 1/118 (0.8%) 1
    Malnutrition 0/232 (0%) 0 1/118 (0.8%) 1
    Metabolic acidosis 1/232 (0.4%) 1 0/118 (0%) 0
    Obesity 0/232 (0%) 0 1/118 (0.8%) 1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 0/232 (0%) 0 1/118 (0.8%) 1
    Muscular weakness 1/232 (0.4%) 1 0/118 (0%) 0
    Musculoskeletal pain 1/232 (0.4%) 1 0/118 (0%) 0
    Osteonecrosis 3/232 (1.3%) 3 0/118 (0%) 0
    Osteoporotic fracture 0/232 (0%) 0 1/118 (0.8%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal cancer 3/232 (1.3%) 3 1/118 (0.8%) 1
    B-cell lymphoma 1/232 (0.4%) 1 0/118 (0%) 0
    Basal cell carcinoma 5/232 (2.2%) 8 3/118 (2.5%) 3
    Bowen's disease 2/232 (0.9%) 2 0/118 (0%) 0
    Colon cancer 1/232 (0.4%) 1 0/118 (0%) 0
    Colon cancer metastatic 1/232 (0.4%) 1 0/118 (0%) 0
    Colorectal cancer 1/232 (0.4%) 1 0/118 (0%) 0
    Colorectal cancer metastatic 1/232 (0.4%) 1 0/118 (0%) 0
    Colorectal cancer recurrent 1/232 (0.4%) 1 0/118 (0%) 0
    Diffuse large B-cell lymphoma 0/232 (0%) 0 1/118 (0.8%) 1
    Hodgkin's disease 1/232 (0.4%) 1 0/118 (0%) 0
    Kaposi's sarcoma AIDS related 4/232 (1.7%) 4 0/118 (0%) 0
    Lip neoplasm malignant stage unspecified 0/232 (0%) 0 1/118 (0.8%) 1
    Lung neoplasm malignant 1/232 (0.4%) 1 0/118 (0%) 0
    Lymphoma 0/232 (0%) 0 1/118 (0.8%) 1
    Non-Hodgkin's lymphoma 1/232 (0.4%) 1 0/118 (0%) 0
    Oral neoplasm 1/232 (0.4%) 1 0/118 (0%) 0
    Rectal cancer 1/232 (0.4%) 1 0/118 (0%) 0
    Skin cancer 1/232 (0.4%) 1 0/118 (0%) 0
    Squamous cell carcinoma 2/232 (0.9%) 5 3/118 (2.5%) 5
    Squamous cell carcinoma of skin 2/232 (0.9%) 2 0/118 (0%) 0
    T-cell lymphoma 1/232 (0.4%) 1 0/118 (0%) 0
    Tongue neoplasm malignant stage unspecified 1/232 (0.4%) 1 0/118 (0%) 0
    Vulval cancer stage 0 0/232 (0%) 0 1/118 (0.8%) 1
    Nervous system disorders
    Cerebral haemorrhage 0/232 (0%) 0 1/118 (0.8%) 1
    Cerebral infarction 1/232 (0.4%) 1 1/118 (0.8%) 1
    Cerebral ischaemia 1/232 (0.4%) 1 0/118 (0%) 0
    Cerebrovascular accident 2/232 (0.9%) 3 1/118 (0.8%) 1
    Convulsion 1/232 (0.4%) 1 2/118 (1.7%) 3
    Encephalitis 1/232 (0.4%) 1 0/118 (0%) 0
    Epilepsy 0/232 (0%) 0 1/118 (0.8%) 4
    Hydrocephalus 1/232 (0.4%) 1 0/118 (0%) 0
    Hypoaesthesia 0/232 (0%) 0 1/118 (0.8%) 1
    Ischaemic stroke 1/232 (0.4%) 1 0/118 (0%) 0
    Parkinsonism 1/232 (0.4%) 1 0/118 (0%) 0
    Poor quality sleep 0/232 (0%) 0 1/118 (0.8%) 1
    Psychomotor hyperactivity 0/232 (0%) 0 1/118 (0.8%) 1
    Syncope 1/232 (0.4%) 1 0/118 (0%) 0
    Psychiatric disorders
    Depression 0/232 (0%) 0 2/118 (1.7%) 3
    Disturbance in social behaviour 0/232 (0%) 0 1/118 (0.8%) 1
    Panic attack 0/232 (0%) 0 1/118 (0.8%) 1
    Psychotic disorder 0/232 (0%) 0 1/118 (0.8%) 1
    Substance abuse 1/232 (0.4%) 1 0/118 (0%) 0
    Suicide attempt 1/232 (0.4%) 1 0/118 (0%) 0
    Renal and urinary disorders
    Calculus urinary 1/232 (0.4%) 1 0/118 (0%) 0
    Focal segmental glomerulosclerosis 1/232 (0.4%) 1 0/118 (0%) 0
    Nephrolithiasis 1/232 (0.4%) 1 0/118 (0%) 0
    Nephropathy 0/232 (0%) 0 1/118 (0.8%) 1
    Nephropathy toxic 1/232 (0.4%) 1 0/118 (0%) 0
    Nephrotic syndrome 1/232 (0.4%) 1 0/118 (0%) 0
    Proteinuria 1/232 (0.4%) 1 0/118 (0%) 0
    Renal failure 1/232 (0.4%) 1 0/118 (0%) 0
    Renal failure acute 2/232 (0.9%) 2 0/118 (0%) 0
    Renal tubular necrosis 1/232 (0.4%) 1 0/118 (0%) 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/232 (0.4%) 1 0/118 (0%) 0
    Epididymal cyst 1/232 (0.4%) 1 0/118 (0%) 0
    Epididymitis 1/232 (0.4%) 1 0/118 (0%) 0
    Gynaecomastia 0/232 (0%) 0 1/118 (0.8%) 1
    Oedema genital 0/232 (0%) 0 1/118 (0.8%) 1
    Ovarian necrosis 1/232 (0.4%) 1 0/118 (0%) 0
    Prostatitis 2/232 (0.9%) 2 1/118 (0.8%) 1
    Uterine prolapse 1/232 (0.4%) 1 0/118 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/232 (0.4%) 1 0/118 (0%) 0
    Haemoptysis 1/232 (0.4%) 1 0/118 (0%) 0
    Hiccups 1/232 (0.4%) 1 0/118 (0%) 0
    Lung disorder 1/232 (0.4%) 1 1/118 (0.8%) 1
    Pneumonia aspiration 1/232 (0.4%) 1 0/118 (0%) 0
    Pneumothorax 1/232 (0.4%) 1 0/118 (0%) 0
    Pulmonary embolism 1/232 (0.4%) 1 0/118 (0%) 0
    Pulmonary hypertension 0/232 (0%) 0 1/118 (0.8%) 1
    Respiratory distress 1/232 (0.4%) 1 0/118 (0%) 0
    Skin and subcutaneous tissue disorders
    Hidradenitis 0/232 (0%) 0 1/118 (0.8%) 3
    Rash 0/232 (0%) 0 1/118 (0.8%) 1
    Vascular disorders
    Deep vein thrombosis 1/232 (0.4%) 1 0/118 (0%) 0
    Hypotension 0/232 (0%) 0 1/118 (0.8%) 1
    Hypovolaemic shock 1/232 (0.4%) 1 0/118 (0%) 0
    Shock 1/232 (0.4%) 1 0/118 (0%) 0
    Varicophlebitis 0/232 (0%) 0 1/118 (0.8%) 1
    Venous thrombosis 1/232 (0.4%) 1 0/118 (0%) 0
    Other (Not Including Serious) Adverse Events
    Raltegravir 400 mg b.i.d Plus OBT Placebo Plus OBT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 206/232 (88.8%) 104/118 (88.1%)
    Blood and lymphatic system disorders
    Anaemia 9/232 (3.9%) 12 7/118 (5.9%) 13
    Lymphadenopathy 19/232 (8.2%) 19 5/118 (4.2%) 8
    Gastrointestinal disorders
    Abdominal pain 15/232 (6.5%) 16 11/118 (9.3%) 12
    Diarrhoea 74/232 (31.9%) 110 34/118 (28.8%) 70
    Gastritis 8/232 (3.4%) 8 7/118 (5.9%) 8
    Haemorrhoids 12/232 (5.2%) 12 2/118 (1.7%) 2
    Nausea 30/232 (12.9%) 38 20/118 (16.9%) 25
    Vomiting 18/232 (7.8%) 26 17/118 (14.4%) 25
    General disorders
    Asthenia 15/232 (6.5%) 16 11/118 (9.3%) 11
    Fatigue 18/232 (7.8%) 18 6/118 (5.1%) 9
    Injection site reaction 18/232 (7.8%) 19 14/118 (11.9%) 16
    Pyrexia 28/232 (12.1%) 35 18/118 (15.3%) 23
    Infections and infestations
    Anogenital warts 11/232 (4.7%) 14 6/118 (5.1%) 7
    Bronchitis 42/232 (18.1%) 71 16/118 (13.6%) 23
    Gastroenteritis 22/232 (9.5%) 28 3/118 (2.5%) 4
    Genital herpes 10/232 (4.3%) 11 9/118 (7.6%) 12
    Herpes simplex 12/232 (5.2%) 13 3/118 (2.5%) 6
    Herpes zoster 20/232 (8.6%) 23 7/118 (5.9%) 10
    Influenza 25/232 (10.8%) 28 8/118 (6.8%) 11
    Nasopharyngitis 58/232 (25%) 96 21/118 (17.8%) 51
    Oral candidiasis 11/232 (4.7%) 14 15/118 (12.7%) 20
    Pharyngitis 15/232 (6.5%) 24 8/118 (6.8%) 11
    Pneumonia 9/232 (3.9%) 12 9/118 (7.6%) 11
    Respiratory tract infection 19/232 (8.2%) 21 3/118 (2.5%) 5
    Sinusitis 11/232 (4.7%) 15 6/118 (5.1%) 13
    Upper respiratory tract infection 20/232 (8.6%) 35 7/118 (5.9%) 15
    Urinary tract infection 14/232 (6%) 17 6/118 (5.1%) 8
    Investigations
    Alanine aminotransferase increased 24/232 (10.3%) 40 9/118 (7.6%) 19
    Aspartate aminotransferase increased 24/232 (10.3%) 30 8/118 (6.8%) 18
    Blood cholesterol increased 28/232 (12.1%) 44 9/118 (7.6%) 20
    Blood triglycerides increased 22/232 (9.5%) 30 11/118 (9.3%) 14
    Weight decreased 6/232 (2.6%) 8 7/118 (5.9%) 7
    Metabolism and nutrition disorders
    Decreased appetite 12/232 (5.2%) 13 6/118 (5.1%) 6
    Diabetes mellitus 6/232 (2.6%) 7 6/118 (5.1%) 6
    Musculoskeletal and connective tissue disorders
    Arthralgia 14/232 (6%) 15 7/118 (5.9%) 8
    Back pain 26/232 (11.2%) 33 10/118 (8.5%) 14
    Muscle spasms 12/232 (5.2%) 15 7/118 (5.9%) 7
    Myalgia 9/232 (3.9%) 9 8/118 (6.8%) 9
    Pain in extremity 12/232 (5.2%) 16 6/118 (5.1%) 6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma 16/232 (6.9%) 20 6/118 (5.1%) 8
    Nervous system disorders
    Dizziness 14/232 (6%) 15 2/118 (1.7%) 2
    Headache 28/232 (12.1%) 38 24/118 (20.3%) 29
    Psychiatric disorders
    Depression 13/232 (5.6%) 14 9/118 (7.6%) 10
    Insomnia 24/232 (10.3%) 24 12/118 (10.2%) 14
    Respiratory, thoracic and mediastinal disorders
    Cough 20/232 (8.6%) 24 11/118 (9.3%) 14
    Skin and subcutaneous tissue disorders
    Eczema 6/232 (2.6%) 7 7/118 (5.9%) 7
    Lipodystrophy acquired 11/232 (4.7%) 11 6/118 (5.1%) 6
    Pruritus 16/232 (6.9%) 20 6/118 (5.1%) 6
    Rash 20/232 (8.6%) 25 7/118 (5.9%) 12
    Vascular disorders
    Hypertension 32/232 (13.8%) 32 12/118 (10.2%) 12

    Limitations/Caveats

    Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00293267
    Other Study ID Numbers:
    • 0518-018
    • 2005_096
    First Posted:
    Feb 17, 2006
    Last Update Posted:
    Sep 7, 2015
    Last Verified:
    Sep 1, 2015