Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138) (RACING)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01048671 |
Recruitment Status
:
Completed
First Posted
: January 14, 2010
Results First Posted
: February 14, 2014
Last Update Posted
: October 30, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Study Type: | Observational |
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Study Design: | Observational Model: Cohort; Time Perspective: Prospective |
Condition: |
HIV Infections |
Interventions: |
Drug: Raltegravir Drug: ARV (non-raltegravir) |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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No text entered. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Of 482 participants included in the trial, 2 were excluded from analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. |
Reporting Groups
Description | |
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ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Participant Flow: Overall Study
ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | |
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STARTED | 66 | 264 | 152 |
COMPLETED | 66 | 263 | 151 |
NOT COMPLETED | 0 | 1 | 1 |
Protocol Violation | 0 | 1 | 1 |

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. |
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No text entered. |
Reporting Groups
Description | |
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ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met). |
Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met). |
Total | Total of all reporting groups |
Baseline Measures
ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | Total | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
66 | 263 | 151 | 480 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Age [Units: Years] Mean (Standard Deviation) |
42.9 (12.0) | 47.3 (10.1) | 46.5 (10.4) | 46.4 (10.6) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gender [Units: Participants] |
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Female | 17 | 91 | 65 | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 49 | 172 | 86 | 307 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis [Units: Years] Mean (Standard Deviation) |
2.8 (4.7) | 13.0 (7.0) | 11.6 (7.5) | 11.1 (7.7) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir [ Time Frame: Up to 25 months after start of raltegravir treatment ] |
Measure Type | Primary |
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Measure Title | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir |
Measure Description | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others. |
Time Frame | Up to 25 months after start of raltegravir treatment |
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. |
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Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants. |
Reporting Groups
Description | |
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Antiretroviral Combination Therapy Including Raltegravir | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Measured Values
Antiretroviral Combination Therapy Including Raltegravir | |
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Participants Analyzed [Units: Participants] |
477 |
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir [Units: Percentage of participants] |
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FTC/TDF + raltegravir | 44.4 |
3TC/ABC + raltegravir | 14.0 |
Other 2 NRTIs + raltegravir | 1.3 |
Mulitple (>=3 ) ARV therapies + raltegravir | 15.7 |
Protease inhibitor + raltegravir | 8.8 |
Other strategies (each <5%) | 15.7 |
No statistical analysis provided for Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
2. Primary: | Percentage of Participants Responding to Treatment: All Treated Participants [ Time Frame: 24 months after start of raltegravir treatment ] |
Measure Type | Primary |
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Measure Title | Percentage of Participants Responding to Treatment: All Treated Participants |
Measure Description | Response to treatment was defined as a viral load <50 RNA copies/mL |
Time Frame | 24 months after start of raltegravir treatment |
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. |
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All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. |
Reporting Groups
Description | |
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ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Measured Values
ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | All Participants | |
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Participants Analyzed [Units: Participants] |
52 | 230 | 125 | 407 |
Percentage of Participants Responding to Treatment: All Treated Participants [Units: Percentage of participants] Number (95% Confidence Interval) |
94.2 (87.9 to 100.6) |
94.3 (91.4 to 97.3) |
71.2 (63.3 to 79.1) |
87.2 (84.0 to 90.5) |
No statistical analysis provided for Percentage of Participants Responding to Treatment: All Treated Participants
3. Primary: | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 [ Time Frame: 24 months after start of raltegravir treatment ] |
Measure Type | Primary |
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Measure Title | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 |
Measure Description | Response to treatment was defined as a viral load <50 RNA copies/mL |
Time Frame | 24 months after start of raltegravir treatment |
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. |
---|
All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. |
Reporting Groups
Description | |
---|---|
ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Measured Values
ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | All Participants | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
39 | 194 | 94 | 327 |
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 [Units: Percentage of participants] Number (95% Confidence Interval) |
94.9 (87.9 to 101.8) |
95.4 (92.4 to 98.3) |
77.7 (69.2 to 86.1) |
90.2 (87.0 to 93.4) |
No statistical analysis provided for Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
4. Primary: | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants [ Time Frame: Baseline and 24 months after start of raltegravir treatment ] |
Measure Type | Primary |
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Measure Title | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants |
Measure Description | No text entered. |
Time Frame | Baseline and 24 months after start of raltegravir treatment |
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. |
---|
All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. |
Reporting Groups
Description | |
---|---|
ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Measured Values
ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | All Participants | |
---|---|---|---|---|
Participants Analyzed [Units: Participants] |
55 | 229 | 123 | 407 |
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants [Units: Cells/mm^3] Mean (95% Confidence Interval) |
260.58 (208.75 to 312.41) |
47.97 (19.57 to 76.36) |
149.98 (113.71 to 186.26) |
107.53 (85.80 to 129.29) |
No statistical analysis provided for Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
5. Primary: | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 [ Time Frame: Baseline and 24 months after start of raltegravir treatment ] |
Measure Type | Primary |
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Measure Title | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 |
Measure Description | No text entered. |
Time Frame | Baseline and 24 months after start of raltegravir treatment |
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. |
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All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. |
Reporting Groups
Description | |
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ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Measured Values
ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | All Participants | |
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Participants Analyzed [Units: Participants] |
39 | 194 | 91 | 324 |
Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 [Units: Cells/mm^3] Mean (95% Confidence Interval) |
285.05 (219.96 to 350.15) |
49.21 (16.38 to 82.03) |
150.87 (110.88 to 190.86) |
106.15 (80.87 to 131.43) |
No statistical analysis provided for Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
6. Secondary: | Number of Participants With at Least One Adverse Event [ Time Frame: Up to 25 months after start of raltegravir treatment ] |
Measure Type | Secondary |
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Measure Title | Number of Participants With at Least One Adverse Event |
Measure Description | An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor’s product whether or not related to the use of the product. |
Time Frame | Up to 25 months after start of raltegravir treatment |
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. |
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Participants enrolled and not excluded for a protocol violation were included in the analysis. |
Reporting Groups
Description | |
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Antiretroviral Combination Therapy Including Raltegravir | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
Measured Values
Antiretroviral Combination Therapy Including Raltegravir | |
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Participants Analyzed [Units: Participants] |
480 |
Number of Participants With at Least One Adverse Event [Units: Participants] |
287 |
No statistical analysis provided for Number of Participants With at Least One Adverse Event

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 |
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No text entered. |