HIV, Infectious
Conditions
Keywords
HIV, AIDS, Immunodeficiency Virus, Human, Females, Women, PREZISTA, darunavir, TMC114, Protease Inhibitor
Brief summary
The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
Detailed description
This is a multi-center, open-label (doctors and patients know which drug is being administered), Phase IIIb clinical trial to evaluate differences in effectiveness, safety, and tolerability of darunavir/ritonavir by sex and/or race over a 48-week treatment period. This study will be conducted in HIV positive women and men who have been treated previously with antiretroviral therapy. This study will enroll 70% women and will be conducted in the U.S., Puerto Rico, Mexico and Canada in approximately 420 patients who will receive darunavir 600 mg and ritonavir 100 mg twice daily. The primary objective of this study is to determine the percentage of patients who achieve virologic response, defined as a viral load (VL) of \<50 copies/mL at week 48. Secondary study objectives include comparisons of endpoints between women and men as well as race across multiple parameters including but not limited to change in CD4 count from baseline to week 48, time to loss of virologic response (TLOVR), changes in metabolic parameters (blood chemistry), etc. Within 4 weeks after the Screening Visit (initial visit with investigator to determine eligibility), the Investigator should have received all data required to determine the patient's eligibility and will construct the individual Optimized Background Regimen (OBR) that will be used during the treatment period in combination with darunavir/ritonavir for those patients enrolled in the study. The OBR will consist of additional antiretroviral (ARV) agents that will also be administered during the study chosen by the Investigator and based on resistance testing and prior treatment history. The study Sponsor will provide the following ARV agents, that may be used as options for the OBR: TMC 125 (investigational non-nucleoside reverse transcriptase inhibitor; NNRTI); Truvada (tenofovir/emtricitabine); Viread (tenofovir); Emtriva (emtricitabine); Zidovudine. Other NRTIs (nucleoside reverse transcriptase inhibitors) or NNRTIs may be used at the discretion of the Investigator, but will not be provided by the Sponsor. The Baseline Visit (Day 1) will be followed by a 48-week treatment period during which patients will be evaluated at Weeks 4, 8, 12, 16, 24, 36, 48 and at a final Follow-Up Visit during Week 52. (total of 10 visits from Screening to final visit). At a number of visits throughout the study, blood samples will be obtained to assess defined laboratory values, safety parameters and to determine concentrations of study drugs darunavir, TMC125 (if applicable) and ritonavir). Patients will be assessed for change in CD4 count and HIV-RNA throughout the study. At each visit, vital signs will be assessed and patients will be asked about any untoward medical occurrences and these will be recorded as adverse events (AEs) and/or HIV-related events. Detailed definitions and reporting procedures for AEs will be provided as part of the protocol. Study patients will receive PREZISTA (darunavir) 600 mg boosted with 100 mg of ritonavir orally (by mouth) twice a day in combination with other antiretroviral drugs for 48 weeks.
Interventions
DRUGdarunavir
600mg bid for 48 wks
DRUGritonavir
100mg bid for 48 wks
Sponsors
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Tibotec, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented HIV infection * Plasma HIV-RNA \>= 1000 copies/mL * Must be able to comply with protocol requirements
Exclusion criteria
* No prior use of PREZISTA (darunavir), TMC125, enfuvirtide, or tipranavir * No currently active AIDS defining illness, Category C conditions according to the Center for Disease Control \[CDC\] Classification System for HIV Infection (1993) with the following exceptions, which must be discussed with the Sponsor prior to enrollment: stable cutaneous Kaposi's Sarcoma, Wasting syndrome due to HIV infection * Not currently using an investigational drug * Not pregnant or breastfeeding * No Grade 3 or 4 laboratory abnormality as defined by DAIDS (Division of AIDS, National Institute of Allergy and Infectious Diseases).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex | Week 48 | TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability |
| Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex | Week 48 | TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race | Week 48 | TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards. |
| Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | Week 48 | The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards. |
| Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | Baseline, Week 48 | Observed obsevations have no imputation methods applied. |
| Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race | Week 48 | Intention to Treat population (ITT) |
| Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | Week 48 | Last Observation Carried Forward (LOCF) imputation method applied. |
| Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | Week 48 | The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied. |
| Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | Week 48 | The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) |
| Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | Week 48 | The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) |
Countries
Canada, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Female darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks. | 287 |
| Male darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks. | 142 |
| Total | 429 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | AE/HIV-related event | 22 | 6 |
| Overall Study | Ineligible to continue the trial | 2 | 1 |
| Overall Study | Lost to Follow-up | 25 | 9 |
| Overall Study | Non-Adherence | 13 | 6 |
| Overall Study | No virologic response by week 12 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Physician's decision to close the site | 3 | 1 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Subject did not continue visits | 1 | 0 |
| Overall Study | Subject moved out of state | 2 | 0 |
| Overall Study | Subject primary physician's decision | 1 | 0 |
| Overall Study | Subject taking too many different meds | 1 | 0 |
| Overall Study | Subject was too busy for appointments | 1 | 0 |
| Overall Study | Virologic failure | 6 | 4 |
| Overall Study | Withdrawal by Subject | 13 | 6 |
Baseline characteristics
| Characteristic | Male | Total | Female |
|---|---|---|---|
| Age, Continuous | 45 years | 43 years | 43 years |
| CD4+ cell count | 175 cells/L | 200 cells/L | 210 cells/L |
| Plasma log10 copies/mL VL HIV-1 RNA | 4.73 copies/mL STANDARD_DEVIATION 0.856 | 4.67 copies/mL STANDARD_DEVIATION 0.874 | 4.65 copies/mL STANDARD_DEVIATION 0.883 |
| Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) NNRTI: < 1 drug count | 32 participants | 115 participants | 83 participants |
| Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) NNRTI: >= 1 drug count | 110 participants | 314 participants | 204 participants |
| Previous ARV experience: Protease inhibitor (PI) PI: <2 | 50 participants | 169 participants | 119 participants |
| Previous ARV experience: Protease inhibitor (PI) PI: >=2 | 92 participants | 260 participants | 168 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Black | 73 participants | 264 participants | 191 participants |
| Race/Ethnicity, Customized Caucasian/White | 31 participants | 65 participants | 34 participants |
| Race/Ethnicity, Customized Hispanic | 36 participants | 96 participants | 60 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 287 Participants | 287 Participants |
| Sex: Female, Male Male | 142 Participants | 142 Participants | 0 Participants |
| Time since HIV-infection diagnosis | 11.91 years | 11.3 years | 10.78 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 73 / 287 | 33 / 142 |
| serious Total, serious adverse events | 47 / 287 | 33 / 142 |
Outcome results
Primary
Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex
TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Time frame: Week 48
Population: TLOVR non-virologic failure (VF) censored
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Female | Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex | 146 participants |
| Male | Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex | 83 participants |
Primary
Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex
TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability
Time frame: Week 48
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Female | Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex | 146 participants |
| Male | Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex | 83 participants |
Comparison: Confidence interval of the difference in proportion of response between two sexes estimated by:~* Application of delta method to be obtained Standard Error (SE)~* Calculation of lower and upper bound using normal approximation to the difference in response ratesp-value: 0.395% CI: [-19.85, 0.68]Regression, Logistic
Secondary
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values
Observed obsevations have no imputation methods applied.
Time frame: Baseline, Week 48
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 152 x10^6 cells/L | Standard Error 11.2 |
| Male | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 122 x10^6 cells/L | Standard Error 12.3 |
| Hispanic | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 143 x10^6 cells/L | Standard Error 10.8 |
| Asian | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 151 x10^6 cells/L | Standard Error 23.8 |
| Other | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 133 x10^6 cells/L | Standard Error 17 |
| Asian | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 45 x10^6 cells/L | Standard Error 24.5 |
| Other | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values | 179 x10^6 cells/L | — |
Secondary
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)
Last Observation Carried Forward (LOCF) imputation method applied.
Time frame: Week 48
Population: ITT LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 112 x10^6 cells/L | Standard Error 8.8 |
| Male | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 103 x10^6 cells/L | Standard Error 11.2 |
| Hispanic | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 109 x10^6 cells/L | Standard Error 8.9 |
| Asian | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 110 x10^6 cells/L | Standard Error 20.4 |
| Other | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 109 x10^6 cells/L | Standard Error 13.5 |
| Asian | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 45 x10^6 cells/L | Standard Error 24.5 |
| Other | Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) | 138 x10^6 cells/L | Standard Error 41 |
Secondary
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.
Time frame: Week 48
Population: Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 107 x10^6 Cells/L | Standard Error 12.7 |
| Male | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 98 x10^6 Cells/L | Standard Error 14 |
| Hispanic | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 113 x10^6 Cells/L | Standard Error 12.1 |
| Asian | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 84 x10^6 Cells/L | Standard Error 21.7 |
| Other | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 90 x10^6 Cells/L | Standard Error 22.6 |
| Asian | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 45 x10^6 Cells/L | Standard Error 24.5 |
| Other | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF | 138 x10^6 Cells/L | Standard Error 41 |
Secondary
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
Time frame: Week 48
Population: Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 136 x10^6 cells/L | Standard Error 15.8 |
| Male | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 108 x10^6 cells/L | Standard Error 15.1 |
| Hispanic | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 135 x10^6 cells/L | Standard Error 13.5 |
| Asian | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 111 x10^6 cells/L | Standard Error 26.7 |
| Other | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 98 x10^6 cells/L | Standard Error 29.8 |
| Asian | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 45 x10^6 cells/L | Standard Error 24.5 |
| Other | Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values | 179 x10^6 cells/L | — |
Secondary
Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Time frame: Week 48
Population: Etravirine-TMC125 (ETR) Subgroup \[TLOVR Non-virologic Failure (VF) Censored\]
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Female | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 69 participants |
| Male | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 54 participants |
| Hispanic | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 74 participants |
| Asian | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 21 participants |
| Other | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 25 participants |
| Asian | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 2 participants |
| Other | Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA | 1 participants |
Secondary
Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race
TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Time frame: Week 48
Population: TLOVR Non-virologic Failure(VF) Censored
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Female | Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race | 128 participants |
| Male | Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race | 39 participants |
| Hispanic | Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race | 59 participants |
| Asian | Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race | 2 participants |
| Other | Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race | 1 participants |
Secondary
Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
Time frame: Week 48
Population: ETR Subgroup- Intention to Treat population (ITT)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Female | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 69 participants | 0.088 |
| Male | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 54 participants | 0.131 |
| Hispanic | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 74 participants | 0.092 |
| Asian | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 21 participants | 0.191 |
| Other | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 25 participants | 0.158 |
| Asian | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 2 participants | 0.472 |
| Other | Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects | 1 participants | -1.73 |
Secondary
Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race
Intention to Treat population (ITT)
Time frame: Week 48
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Female | Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race | 128 participants |
| Male | Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race | 39 participants |
| Hispanic | Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race | 59 participants |
| Asian | Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race | 2 participants |
| Other | Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race | 1 participants |