Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138) (RACING)

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	HIV Infections
Interventions:	Drug: Raltegravir; Drug: ARV (non-raltegravir)

  Participant Flow

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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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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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
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
STARTED	66	264	152
COMPLETED	66	263	151
NOT COMPLETED	0	1	1
Protocol Violation	0	1	1

  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.
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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. 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
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]
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)

  Outcome Measures

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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
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.
Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.

Reporting Groups

	Description
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
Participants Analyzed; [Units: Participants]	477
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir; [Units: Percentage of participants]
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
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.
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
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]	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
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
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
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.
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
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	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
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.
Participants enrolled and not excluded for a protocol violation were included in the analysis.

Reporting Groups

	Description
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
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

  Serious Adverse Events

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  Other Adverse Events

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  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
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