HIV Infections
Conditions
Keywords
HIV
Brief summary
To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.
Interventions
DRUGRaltegravir
Raltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily.
DRUGARV (non-raltegravir)
ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant Infected With HIV-1. * Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study. * Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.
Exclusion criteria
* Participant taking part in a clinical trial to assess raltegravir. * Participant in whom raltegravir treatment was started more than 30 days ago.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | Up to 25 months after start of raltegravir treatment | 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. |
| Percentage of Participants Responding to Treatment: All Treated Participants | 24 months after start of raltegravir treatment | Response to treatment was defined as a viral load \<50 RNA copies/mL |
| Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | 24 months after start of raltegravir treatment | Response to treatment was defined as a viral load \<50 RNA copies/mL |
| Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | Baseline and 24 months after start of raltegravir treatment | — |
| Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | Baseline and 24 months after start of raltegravir treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Adverse Event | Up to 25 months after start of raltegravir treatment | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| 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). | 263 |
| 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). | 151 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | ARV naïve at Baseline | Suppressed at Baseline | Virological Failure at Baseline | Total |
|---|---|---|---|---|
| Age, Continuous | 42.9 Years STANDARD_DEVIATION 12 | 47.3 Years STANDARD_DEVIATION 10.1 | 46.5 Years STANDARD_DEVIATION 10.4 | 46.4 Years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 17 Participants | 91 Participants | 65 Participants | 173 Participants |
| Sex: Female, Male Male | 49 Participants | 172 Participants | 86 Participants | 307 Participants |
| Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis | 2.8 Years STANDARD_DEVIATION 4.7 | 13.0 Years STANDARD_DEVIATION 7 | 11.6 Years STANDARD_DEVIATION 7.5 | 11.1 Years STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 480 |
| serious Total, serious adverse events | 66 / 480 |
Outcome results
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antiretroviral Combination Therapy Including Raltegravir | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | 285.05 cells/mm^3 |
| Suppressed at Baseline | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | 49.21 cells/mm^3 |
| Virological Failure at Baseline | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | 150.87 cells/mm^3 |
| All Participants | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | 106.15 cells/mm^3 |
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antiretroviral Combination Therapy Including Raltegravir | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | 260.58 cells/mm^3 |
| Suppressed at Baseline | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | 47.97 cells/mm^3 |
| Virological Failure at Baseline | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | 149.98 cells/mm^3 |
| All Participants | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | 107.53 cells/mm^3 |
Primary
Percentage of Participants Receiving Antiretroviral Treatments Administered With 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. 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: Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | FTC/TDF + raltegravir | 44.4 Percentage of participants |
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | 3TC/ABC + raltegravir | 14.0 Percentage of participants |
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | Other 2 NRTIs + raltegravir | 1.3 Percentage of participants |
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | Mulitple (>=3 ) ARV therapies + raltegravir | 15.7 Percentage of participants |
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | Protease inhibitor + raltegravir | 8.8 Percentage of participants |
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | Other strategies (each <5%) | 15.7 Percentage of participants |
Primary
Percentage of Participants Responding to Treatment: All Treated Participants
Response to treatment was defined as a viral load \<50 RNA copies/mL
Time frame: 24 months after start of raltegravir treatment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Responding to Treatment: All Treated Participants | 94.2 Percentage of participants |
| Suppressed at Baseline | Percentage of Participants Responding to Treatment: All Treated Participants | 94.3 Percentage of participants |
| Virological Failure at Baseline | Percentage of Participants Responding to Treatment: All Treated Participants | 71.2 Percentage of participants |
| All Participants | Percentage of Participants Responding to Treatment: All Treated Participants | 87.2 Percentage of participants |
Primary
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
Response to treatment was defined as a viral load \<50 RNA copies/mL
Time frame: 24 months after start of raltegravir treatment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antiretroviral Combination Therapy Including Raltegravir | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | 94.9 Percentage of participants |
| Suppressed at Baseline | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | 95.4 Percentage of participants |
| Virological Failure at Baseline | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | 77.7 Percentage of participants |
| All Participants | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | 90.2 Percentage of participants |
Secondary
Number of Participants With at Least One Adverse Event
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: Participants enrolled and not excluded for a protocol violation were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antiretroviral Combination Therapy Including Raltegravir | Number of Participants With at Least One Adverse Event | 287 Participants |