HIV-1 Infections
Conditions
Keywords
Treatment Naive
Brief summary
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Detailed description
Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV). The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial. After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry. RAL and DRV were provided by the study. RTV was not provided by the study.
Interventions
DRUGRaltegravir
400 mg tablet taken orally twice daily
800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1-infected * Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry * HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol. * ARV drug-naive. More information on this criterion can be found in the protocol. * Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry * Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.
Exclusion criteria
* Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol. * Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation \[RAM\] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone * Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S * Severe renal insufficiency requiring hemodialysis or peritoneal dialysis * Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol. * Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol. * Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion. * Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study. * Certain abnormal laboratory results. More information on this criterion can be found in the protocol. * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 | From start of study treatment to week 24 | Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \>= 1000 copies/ml or confirmed rebound from the week 4 value by \>0.5 log10 copies/ml (for subjects with week 4 value \<= 50 copies/ml, confirmed rebound to \>50 copies/ml); at week 24 or later, confirmed value \> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma HIV-1 RNA From Baseline to Week 1 | Baseline and week 1 | Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry. |
| Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 | From start of study treatment to week 24 | Results report the percentage of participants with plasma HIV-1 RNA \< 50 copies/ml or \<200 copies/ml at week 24. |
| Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 | From start of study treatment to week 48 | Results report the percentage of participants with plasma HIV-1 RNA \<50 copies/ml or \<200 copies/ml at week 48. |
| Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment | From start of study treatment to week 52 | Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment. |
| Number of Participants With Pretreatment Drug Resistance | At screening | Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant. |
| Number of Participants With Integrase Drug Resistance at Virologic Failure | From 12 weeks after starting study treatment to week 52 | Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure. |
| Number of Participants With Protease Drug Resistance at Virologic Failure | From 12 weeks after starting study treatment to week 52 | Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure. |
| Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24 | From start of study treatment to Week 24 | The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval. |
| Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 | From start of study treatment through week 24 | Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride. |
| Change in Fasting Low-density Lipoprotein at Week 24 | From start of study treatment through week 24 | Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride. |
| Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 | From start of study treatment through week 48 | Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride. |
| Change in Fasting Low-density Lipoprotein at Week 48 | From start of study treatment through week 48 | Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride. |
| Change in CD4 Count at Week 48 | From start of study treatment through week 48 | Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry. |
| Plasma Trough Concentration of Raltegravir | From start of study treatment to week 52 | Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation. |
| Plasma Trough Concentration of Darunavir | From start of study treatment to week 52 | Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation. |
| Number of Participants With Perfect Overall Adherence by Self Report | From one week after starting study treatment to week 52 | At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence. |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from 22 U.S. sites from April 2009 to August 2009.
Pre-assignment details
Study participants were HIV-1-infected, antiretroviral(ARV)-naive men and women, 18 years and older with plasma HIV-1 RNA \>= 5000 copies/ml. One enrolled participant never started study treatment.
Participants by arm
| Arm | Count |
|---|---|
| RAL+DRV/RTV Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consent withdrawn | 2 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Unable to get to clinic | 7 |
| Overall Study | Unwilling to adhere to study requirement | 1 |
Baseline characteristics
| Characteristic | RAL+DRV/RTV |
|---|---|
| Age, Continuous | 36 years FULL_RANGE 11 |
| Age, Customized 18-29 | 33 participants |
| Age, Customized 30-39 | 38 participants |
| Age, Customized 40-49 | 25 participants |
| Age, Customized 50-59 | 12 participants |
| Age, Customized 60-69 | 4 participants |
| Region of Enrollment United States | 112 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 112 |
| serious Total, serious adverse events | 13 / 112 |
Outcome results
Primary
Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24
Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \>= 1000 copies/ml or confirmed rebound from the week 4 value by \>0.5 log10 copies/ml (for subjects with week 4 value \<= 50 copies/ml, confirmed rebound to \>50 copies/ml); at week 24 or later, confirmed value \> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Time frame: From start of study treatment to week 24
Population: All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAL+DRV/RTV | Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 | 0.16 Proportion of participants |
Secondary
Change in CD4 Count at Week 48
Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.
Time frame: From start of study treatment through week 48
Population: Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAL+DRV/RTV | Change in CD4 Count at Week 48 | 200 cells/mm3 |
Secondary
Change in Fasting Low-density Lipoprotein at Week 24
Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Time frame: From start of study treatment through week 24
Population: Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAL+DRV/RTV | Change in Fasting Low-density Lipoprotein at Week 24 | 16.0 mg/dL |
Secondary
Change in Fasting Low-density Lipoprotein at Week 48
Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Time frame: From start of study treatment through week 48
Population: Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAL+DRV/RTV | Change in Fasting Low-density Lipoprotein at Week 48 | 17 mg/dL |
Secondary
Change in Plasma HIV-1 RNA From Baseline to Week 1
Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.
Time frame: Baseline and week 1
Population: Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAL+DRV/RTV | Change in Plasma HIV-1 RNA From Baseline to Week 1 | -1.67 log10 copies/ml |
Secondary
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24
Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Time frame: From start of study treatment through week 24
Population: Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RAL+DRV/RTV | Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 | Fasting Total Cholesterol | 31.5 mg/dL |
| RAL+DRV/RTV | Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 | Fasting High-density Lipoprotein | 6.5 mg/dL |
| RAL+DRV/RTV | Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 | Fasting Triglyceride | 24.5 mg/dL |
Secondary
Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48
Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Time frame: From start of study treatment through week 48
Population: Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RAL+DRV/RTV | Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 | Fasting Total Cholesterol | 30 mg/dL |
| RAL+DRV/RTV | Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 | Fasting High-density Lipoprotein | 9 mg/dL |
| RAL+DRV/RTV | Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 | Fasting Triglyceride | 23 mg/dL |
Secondary
Number of Participants With Integrase Drug Resistance at Virologic Failure
Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.
Time frame: From 12 weeks after starting study treatment to week 52
Population: Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAL+DRV/RTV | Number of Participants With Integrase Drug Resistance at Virologic Failure | 5 participants |
Secondary
Number of Participants With Perfect Overall Adherence by Self Report
At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence.
Time frame: From one week after starting study treatment to week 52
Population: All participants who started study treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAL+DRV/RTV | Number of Participants With Perfect Overall Adherence by Self Report | 95 participants |
Secondary
Number of Participants With Pretreatment Drug Resistance
Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.
Time frame: At screening
Population: All participants who started study treatment were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RAL+DRV/RTV | Number of Participants With Pretreatment Drug Resistance | With NNRTI mutations only | 9 participants |
| RAL+DRV/RTV | Number of Participants With Pretreatment Drug Resistance | With Both NNRTI and NRTI mutations | 1 participants |
| RAL+DRV/RTV | Number of Participants With Pretreatment Drug Resistance | With PI mutations only | 2 participants |
| RAL+DRV/RTV | Number of Participants With Pretreatment Drug Resistance | With PI, NNRTI and NRTI mutations | 1 participants |
| RAL+DRV/RTV | Number of Participants With Pretreatment Drug Resistance | With NRTI mutations only | 8 participants |
| RAL+DRV/RTV | Number of Participants With Pretreatment Drug Resistance | No Resistance Detected | 91 participants |
Secondary
Number of Participants With Protease Drug Resistance at Virologic Failure
Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.
Time frame: From 12 weeks after starting study treatment to week 52
Population: Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAL+DRV/RTV | Number of Participants With Protease Drug Resistance at Virologic Failure | 0 participants |
Secondary
Plasma Trough Concentration of Darunavir
Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Time frame: From start of study treatment to week 52
Population: Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAL+DRV/RTV | Plasma Trough Concentration of Darunavir | 1218 ng/ml |
Secondary
Plasma Trough Concentration of Raltegravir
Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Time frame: From start of study treatment to week 52
Population: Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RAL+DRV/RTV | Plasma Trough Concentration of Raltegravir | 117 ng/ml |
Secondary
Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment
Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.
Time frame: From start of study treatment to week 52
Population: All participants who started study treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAL+DRV/RTV | Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment | 0.20 proportion of participants |
Secondary
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24
Results report the percentage of participants with plasma HIV-1 RNA \< 50 copies/ml or \<200 copies/ml at week 24.
Time frame: From start of study treatment to week 24
Population: All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RAL+DRV/RTV | Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 | With HIV-1 RNA < 50 copies/ml | 0.79 proportion of participants |
| RAL+DRV/RTV | Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 | With HIV-1 RNA < 200 copies/ml | 0.93 proportion of participants |
Secondary
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48
Results report the percentage of participants with plasma HIV-1 RNA \<50 copies/ml or \<200 copies/ml at week 48.
Time frame: From start of study treatment to week 48
Population: All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RAL+DRV/RTV | Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 | With HIV-1 RNA < 50 copies/ml | 0.71 proportion of participants |
| RAL+DRV/RTV | Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 | With HIV-1 RNA < 200 copies/ml | 0.86 proportion of participants |
Secondary
Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24
The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Time frame: From start of study treatment to Week 24
Population: All participants who started study treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAL+DRV/RTV | Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24 | 0.21 Proportion of participants |