Human Immunodeficiency Virus - Type 1
Conditions
Keywords
Human immunodeficiency virus - type 1, HIV-1 Infection, TMC-114, Darunavir, Ritonavir
Brief summary
The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).
Detailed description
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.
Interventions
DRUGDarunavir (DRV)
DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.
DRUGRitonavir (rtv)
DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.
Sponsors
Tibotec Pharmaceuticals, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with documented human immunodeficiency virus - Type 1 (HIV-1) infection * Patients with a viral load greater than 1,000 HIV-1 ribonucleic acid (RNA) copies/mL * Stable highly active antiretroviral therapy (HAART) regimen for at least 12 weeks at screening * In the investigator's opinion, non-nucleoside reverse transcriptase inhibitors (NNRTIs) are not a valid treatment option, because of the patient's antiretroviral (ARV) treatment history, ARV resistance testing, medication-taking behavior, safety and tolerability concerns, or other patient-related factors * Prescreening or/and screening plasma HIV-1 RNA greater than 1,000 copies/mL on HAART regimen at screening
Exclusion criteria
* Presence of any currently active conditions that fit the definition of the World Health Organization (WHO) Clinical Stage 4, with the following exceptions: stable cutaneous kaposi's sarcoma (ie, no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study time period, wasting syndrome * Patients for whom an investigational ARV is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval): tenofovir, emtricitabine * Previous or current use of enfuvirtide (ENF), tipranavir and/or DRV * Life expectancy of less than 12 months * Pregnant or breast-feeding females * Any active clinically significant disease (eg, tuberculosis \[TB\], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | 48 Weeks | The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4+ Cell Count From Baseline | 48 Weeks | CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm. |
| Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 48 weeks | Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48. |
| Change in log10 Viral Load From Baseline at Week 48 | 48 weeks | — |
| Time to Reach First Virologic Response | 48 weeks | Time (in weeks) to achieve viral load less than 50 copies/mL by the participants. |
| Time to Loss of Virologic Response | 48 weeks | Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants. |
| Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | 48 weeks | — |
| Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | 48 weeks | Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days. |
| Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. | Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. |
| Predose Plasma Concentration (C0h) of DRV and Rtv. | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48 | Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. |
| Number of Participants Developing Mutations at Endpoint | 48 weeks | Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint. |
| Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | 48 weeks | The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening. |
Countries
Argentina, Australia, Austria, Brazil, Chile, France, Germany, Guatemala, Hungary, Malaysia, Panama, Puerto Rico, Romania, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Participant flow
Recruitment details
One hundred thirteen investigators in 21 countries participated in this study.
Pre-assignment details
In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.
Participants by arm
| Arm | Count |
|---|---|
| DRV/Rtv 800/100 mg Once Daily Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily | 294 |
| DRV/Rtv 600/100 mg Twice Daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily | 296 |
| Total | 590 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 12 |
| Overall Study | Ineligible to Continue the study | 2 | 5 |
| Overall Study | Lost to Follow-up | 9 | 13 |
| Overall Study | Non-compliant | 8 | 9 |
| Overall Study | Other | 3 | 2 |
| Overall Study | Reached a Virologic Endpoint | 3 | 2 |
| Overall Study | Sponsor's Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | DRV/Rtv 600/100 mg Twice Daily | Total | DRV/Rtv 800/100 mg Once Daily |
|---|---|---|---|
| Age Continuous | 40.7 years STANDARD_DEVIATION 9.5 | 40.5 years STANDARD_DEVIATION 9.29 | 40.2 years STANDARD_DEVIATION 9.09 |
| Age (years) (categorical) 30 < Age <= 45 | 169 participants | 349 participants | 180 participants |
| Age (years) (categorical) 45 < Age <= 55 | 72 participants | 136 participants | 64 participants |
| Age (years) (categorical) 55 < Age <= 65 | 18 participants | 32 participants | 14 participants |
| Age (years) (categorical) Age <= 30 | 35 participants | 70 participants | 35 participants |
| Age (years) (categorical) Age > 65 | 2 participants | 3 participants | 1 participants |
| Hepatitis B or C Co-infection Status Negative | 255 participants | 522 participants | 267 participants |
| Hepatitis B or C Co-infection Status Positive | 37 participants | 62 participants | 25 participants |
| Hepatitis B or C Co-infection Status Unknown | 4 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 98 Participants | 213 Participants | 115 Participants |
| Sex: Female, Male Male | 198 Participants | 377 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 134 / 294 | 147 / 296 |
| serious Total, serious adverse events | 16 / 294 | 27 / 296 |
Outcome results
Primary
Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.
Time frame: 48 Weeks
Population: Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | 212 Participants |
| DRV/Rtv 600/100 mg Twice Daily | Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | 210 Participants |
Comparison: Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.p-value: <0.00195% CI: [-0.054, 0.092]Regression, Logistic
Secondary
Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv
Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.
Time frame: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.
Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | Population Pharmacokinetic Estimates of DRV | 87788 ng*h/mL |
| DRV/Rtv 800/100 mg Once Daily | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | Population Pharmacokinetic Estimates of rtv | 5776 ng*h/mL |
| DRV/Rtv 600/100 mg Twice Daily | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | Population Pharmacokinetic Estimates of DRV | 109401 ng*h/mL |
| DRV/Rtv 600/100 mg Twice Daily | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | Population Pharmacokinetic Estimates of rtv | 12588 ng*h/mL |
Secondary
Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score
The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.
Time frame: 48 weeks
Population: Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | FAHI score at baseline | 129 Scores on a scale |
| DRV/Rtv 800/100 mg Once Daily | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | Change from baseline in FAHI score at Week 48 | 2.5 Scores on a scale |
| DRV/Rtv 600/100 mg Twice Daily | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | FAHI score at baseline | 123.5 Scores on a scale |
| DRV/Rtv 600/100 mg Twice Daily | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | Change from baseline in FAHI score at Week 48 | 0.0 Scores on a scale |
p-value: 0.76195% CI: [-2.97, 4.06]ANCOVA
Secondary
Change in CD4+ Cell Count From Baseline
CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.
Time frame: 48 Weeks
Population: Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Change in CD4+ Cell Count From Baseline | Value at Baseline | 219 10e6/l |
| DRV/Rtv 800/100 mg Once Daily | Change in CD4+ Cell Count From Baseline | CD4+ cell count change from baseline at Week 48 | 100 10e6/l |
| DRV/Rtv 600/100 mg Twice Daily | Change in CD4+ Cell Count From Baseline | Value at Baseline | 236 10e6/l |
| DRV/Rtv 600/100 mg Twice Daily | Change in CD4+ Cell Count From Baseline | CD4+ cell count change from baseline at Week 48 | 94 10e6/l |
p-value: 0.56295% CI: [-26.09, 14.2]ANCOVA
Secondary
Change in log10 Viral Load From Baseline at Week 48
Time frame: 48 weeks
Population: Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Change in log10 Viral Load From Baseline at Week 48 | Log10 Viral Load at baseline | 4.23 log10 copies/mL |
| DRV/Rtv 800/100 mg Once Daily | Change in log10 Viral Load From Baseline at Week 48 | Log10 Viral Load change from baseline at Week 48 | -2.11 log10 copies/mL |
| DRV/Rtv 600/100 mg Twice Daily | Change in log10 Viral Load From Baseline at Week 48 | Log10 Viral Load at baseline | 4.134 log10 copies/mL |
| DRV/Rtv 600/100 mg Twice Daily | Change in log10 Viral Load From Baseline at Week 48 | Log10 Viral Load change from baseline at Week 48 | -2.13 log10 copies/mL |
p-value: 0.97795% CI: [-0.188, 0.182]ANCOVA
Secondary
Number of Participants Developing Mutations at Endpoint
Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.
Time frame: 48 weeks
Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Number of Participants Developing Mutations at Endpoint | DRV resistance-associated mutation (RAM) | 1 Participants |
| DRV/Rtv 800/100 mg Once Daily | Number of Participants Developing Mutations at Endpoint | Primary (major) protease inhibitor (PI) mutations | 1 Participants |
| DRV/Rtv 800/100 mg Once Daily | Number of Participants Developing Mutations at Endpoint | Protease inhibitor (PI) RAMs | 7 Participants |
| DRV/Rtv 800/100 mg Once Daily | Number of Participants Developing Mutations at Endpoint | Nucleoside reverse transcriptase inhibitor RAMs | 4 Participants |
| DRV/Rtv 600/100 mg Twice Daily | Number of Participants Developing Mutations at Endpoint | Nucleoside reverse transcriptase inhibitor RAMs | 3 Participants |
| DRV/Rtv 600/100 mg Twice Daily | Number of Participants Developing Mutations at Endpoint | DRV resistance-associated mutation (RAM) | 0 Participants |
| DRV/Rtv 600/100 mg Twice Daily | Number of Participants Developing Mutations at Endpoint | Protease inhibitor (PI) RAMs | 4 Participants |
| DRV/Rtv 600/100 mg Twice Daily | Number of Participants Developing Mutations at Endpoint | Primary (major) protease inhibitor (PI) mutations | 0 Participants |
Secondary
Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48
Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.
Time frame: 48 weeks
Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | Adherent | 67.4 Percentage of participants |
| DRV/Rtv 800/100 mg Once Daily | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | Non-adherent | 32.6 Percentage of participants |
| DRV/Rtv 600/100 mg Twice Daily | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | Non-adherent | 39.7 Percentage of participants |
| DRV/Rtv 600/100 mg Twice Daily | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | Adherent | 60.3 Percentage of participants |
Secondary
Predose Plasma Concentration (C0h) of DRV and Rtv.
Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.
Time frame: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48
Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Predose Plasma Concentration (C0h) of DRV and Rtv. | Population Pharmacokinetic Estimates of DRV | 1896 ng/mL |
| DRV/Rtv 800/100 mg Once Daily | Predose Plasma Concentration (C0h) of DRV and Rtv. | Population Pharmacokinetic Estimates of rtv | 59 ng/mL |
| DRV/Rtv 600/100 mg Twice Daily | Predose Plasma Concentration (C0h) of DRV and Rtv. | Population Pharmacokinetic Estimates of DRV | 3197 ng/mL |
| DRV/Rtv 600/100 mg Twice Daily | Predose Plasma Concentration (C0h) of DRV and Rtv. | Population Pharmacokinetic Estimates of rtv | 307 ng/mL |
Secondary
Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks
Time frame: 48 weeks
Population: Intention To Treat (ITT) population: Observed cases
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | -1.77 log10 copies/mL | Standard Error 0.051 |
| DRV/Rtv 600/100 mg Twice Daily | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | -1.74 log10 copies/mL | Standard Error 0.051 |
p-value: 0.71195% CI: [-0.169, 0.115]ANCOVA
Secondary
Time to Loss of Virologic Response
Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.
Time frame: 48 weeks
Population: Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Time to Loss of Virologic Response | 250.235 Days | Standard Error 6.598 |
| DRV/Rtv 600/100 mg Twice Daily | Time to Loss of Virologic Response | 281.743 Days | Standard Error 7.47 |
p-value: 0.71695% CI: [0.699, 1.279]Regression, Cox
Secondary
Time to Reach First Virologic Response
Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.
Time frame: 48 weeks
Population: Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Time to Reach First Virologic Response | 85 Days |
| DRV/Rtv 600/100 mg Twice Daily | Time to Reach First Virologic Response | 85 Days |
p-value: 0.91795% CI: [0.824, 1.191]Cox proportional hazards
Secondary
Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)
Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.
Time frame: 48 weeks
Population: Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRV/Rtv 800/100 mg Once Daily | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 226 Participants |
| DRV/Rtv 600/100 mg Twice Daily | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 227 Participants |
p-value: <0.00195% CI: [-0.06, 0.075]Regression, Logistic