HIV-1
Conditions
Keywords
HIV-1, Rollover, Safety., HIV Infections, treatment experienced
Brief summary
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
Detailed description
To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.
Interventions
DRUGNo drug will be administered
No drug will be administered.
Sponsors
ViiV Healthcare
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous participation in a qualifying study. * Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
Exclusion criteria
* Concurrent treatment in another clinical trial. * Unwilling or unable to be followed for 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | End of Study visit or the Early Termination visit | The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline, Month 6, Month 12 and Last visit | Number of participants with HIV-1 RNA level \<50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit. |
| Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline, Month 6, Month 12 and Last visit | Number of participants with HIV-1 RNA level \<50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs. |
| Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline, Month 6 and Month 12 | Participant's immunological status assessed by CD4+ lymphocyte count. |
| CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline, Month 6 and Month 12 | Participant's immunological status assessed by CD4+ lymphocyte count. |
Countries
Argentina, Brazil, Italy, Malaysia, Poland, Portugal, Puerto Rico, South Africa, Switzerland, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants from two parent studies (A5271015 and A5271022) were included if they discontinued treatment due to virologic failure or other reasons. Participants from 6 countries were enrolled into the A5271015 study and the A5271022 study enrolled participants from 8 countries.
Pre-assignment details
Twelve and 40 participants who had received: LRV 500 mg QD, LRV 750 mg QD or efavirenz 600 mg QD (in A5271015);or LRV 750 mg QD, LRV 1000 mg QD or etravirine 200 mg BID (in A5271022) were enrolled and treated with open-label antiretrovirals excluding LRV. Data summaries were provided by the randomized treatment groups of the parent protocol.
Participants by arm
| Arm | Count |
|---|---|
| Participants From A5271015 - Lersivirine 500 mg Arm Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study | 5 |
| Participants From A5271015 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study | 4 |
| Participants From A5271015 - Efavirenz 600 mg Arm Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study | 3 |
| Participants From A5271022 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study | 11 |
| Participants From A5271022 - Lersivirine 1000 mg Arm Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study | 12 |
| Participants From A5271022 - Etravirine 200 mg Arm Participants who had received etravirine 200 mg twice daily in A5271022 parent study | 17 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Nolonger willing to participate in study | 1 | 0 | 1 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Participants From A5271015 - Lersivirine 500 mg Arm | Participants From A5271015 - Lersivirine 750 mg Arm | Participants From A5271015 - Efavirenz 600 mg Arm | Participants From A5271022 - Lersivirine 750 mg Arm | Participants From A5271022 - Lersivirine 1000 mg Arm | Participants From A5271022 - Etravirine 200 mg Arm | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized Participants from A5271015 | 33.8 years STANDARD_DEVIATION 6.1 | 31.5 years STANDARD_DEVIATION 1.7 | 38.3 years STANDARD_DEVIATION 3.2 | NA years | NA years | NA years | 34.2 years STANDARD_DEVIATION 4.8 |
| Age, Customized Participants from A5271022 | NA years | NA years | NA years | 42.7 years STANDARD_DEVIATION 9.1 | 39.1 years STANDARD_DEVIATION 9 | 41.6 years STANDARD_DEVIATION 9.4 | 41.2 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 7 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 2 Participants | 6 Participants | 5 Participants | 6 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 5 | 4 / 4 | 2 / 3 | 6 / 11 | 7 / 12 | 11 / 17 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 3 | 0 / 11 | 0 / 12 | 0 / 17 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.
Time frame: End of Study visit or the Early Termination visit
Population: Safety population consisted of all participants who were enrolled in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with serious adverse events | 0 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with adverse events | 3 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Participants discontinued due to adverse events | 0 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with serious adverse events | 0 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with adverse events | 4 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Participants discontinued due to adverse events | 0 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with serious adverse events | 0 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with adverse events | 2 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Participants discontinued due to adverse events | 0 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with serious adverse events | 0 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with adverse events | 6 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Participants discontinued due to adverse events | 0 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with serious adverse events | 0 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with adverse events | 7 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Participants discontinued due to adverse events | 0 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with adverse events | 11 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Participants discontinued due to adverse events | 0 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events | Number of participants with serious adverse events | 0 Number of participants |
Secondary
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Time frame: Baseline, Month 6 and Month 12
Population: Analysis population consisted of all participants who were enrolled in this study. Only available data were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From A5271015 - Lersivirine 500 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 2, 8, 11, 15) | 456 cells/uL | Standard Deviation 175 |
| Participants From A5271015 - Lersivirine 500 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 2, 3, 6, 7) | 618 cells/uL | Standard Deviation 285 |
| Participants From A5271015 - Lersivirine 500 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 285 cells/uL | Standard Deviation 97 |
| Participants From A5271015 - Lersivirine 750 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 2, 8, 11, 15) | 514 cells/uL | Standard Deviation 195 |
| Participants From A5271015 - Lersivirine 750 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 574 cells/uL | Standard Deviation 274 |
| Participants From A5271015 - Lersivirine 750 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 2, 3, 6, 7) | 607 cells/uL | Standard Deviation 326 |
| Participants From A5271015 - Efavirenz 600 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 2, 8, 11, 15) | 606 cells/uL | Standard Deviation 120 |
| Participants From A5271015 - Efavirenz 600 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 564 cells/uL | Standard Deviation 121 |
| Participants From A5271015 - Efavirenz 600 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 2, 3, 6, 7) | 556 cells/uL | Standard Deviation 65 |
| Participants From A5271022 - Lersivirine 750 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 2, 8, 11, 15) | 615 cells/uL | Standard Deviation 248 |
| Participants From A5271022 - Lersivirine 750 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 473 cells/uL | Standard Deviation 191 |
| Participants From A5271022 - Lersivirine 750 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 2, 3, 6, 7) | 378 cells/uL | Standard Deviation 57 |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 411 cells/uL | Standard Deviation 259 |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 2, 3, 6, 7) | 361 cells/uL | Standard Deviation 309 |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 2, 8, 11, 15) | 413 cells/uL | Standard Deviation 266 |
| Participants From A5271022 - Etravirine 200 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 2, 3, 6, 7) | 452 cells/uL | Standard Deviation 247 |
| Participants From A5271022 - Etravirine 200 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 455 cells/uL | Standard Deviation 212 |
| Participants From A5271022 - Etravirine 200 mg Arm | Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 2, 8, 11, 15) | 451 cells/uL | Standard Deviation 221 |
Secondary
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Time frame: Baseline, Month 6 and Month 12
Population: Analysis population consisted of all participants who were enrolled in this study. Only available data were used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants From A5271015 - Lersivirine 500 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 3, 8, 11, 14) | 36 Percentage of total lymphocytes | Standard Deviation 14 |
| Participants From A5271015 - Lersivirine 500 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 21 Percentage of total lymphocytes | Standard Deviation 10 |
| Participants From A5271015 - Lersivirine 500 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 3, 3, 6, 6) | 38 Percentage of total lymphocytes | Standard Deviation 14 |
| Participants From A5271015 - Lersivirine 750 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 3, 8, 11, 14) | 31 Percentage of total lymphocytes | Standard Deviation 12 |
| Participants From A5271015 - Lersivirine 750 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 29 Percentage of total lymphocytes | Standard Deviation 9 |
| Participants From A5271015 - Lersivirine 750 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 3, 3, 6, 6) | 30 Percentage of total lymphocytes | Standard Deviation 10 |
| Participants From A5271015 - Efavirenz 600 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 3, 8, 11, 14) | 26 Percentage of total lymphocytes | Standard Deviation 1 |
| Participants From A5271015 - Efavirenz 600 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 26 Percentage of total lymphocytes | Standard Deviation 2 |
| Participants From A5271015 - Efavirenz 600 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 3, 3, 6, 6) | 27 Percentage of total lymphocytes | Standard Deviation 7 |
| Participants From A5271022 - Lersivirine 750 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 3, 8, 11, 14) | 28 Percentage of total lymphocytes | Standard Deviation 12 |
| Participants From A5271022 - Lersivirine 750 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 26 Percentage of total lymphocytes | Standard Deviation 10 |
| Participants From A5271022 - Lersivirine 750 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 3, 3, 6, 6) | 26 Percentage of total lymphocytes | Standard Deviation 11 |
| Participants From A5271022 - Lersivirine 1000 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 3, 8, 11, 14) | 22 Percentage of total lymphocytes | Standard Deviation 11 |
| Participants From A5271022 - Lersivirine 1000 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 21 Percentage of total lymphocytes | Standard Deviation 12 |
| Participants From A5271022 - Lersivirine 1000 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 3, 3, 6, 6) | 19 Percentage of total lymphocytes | Standard Deviation 10 |
| Participants From A5271022 - Etravirine 200 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Baseline (N = 4, 4, 3, 11, 12, 17) | 23 Percentage of total lymphocytes | Standard Deviation 8 |
| Participants From A5271022 - Etravirine 200 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 12 (N = 4, 4, 3, 3, 6, 6) | 18 Percentage of total lymphocytes | Standard Deviation 7 |
| Participants From A5271022 - Etravirine 200 mg Arm | CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 | Month 6 (N = 4, 4, 3, 8, 11, 14) | 23 Percentage of total lymphocytes | Standard Deviation 6 |
Secondary
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level \<50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.
Time frame: Baseline, Month 6, Month 12 and Last visit
Population: Analysis population consisted of all participants who were enrolled in this study. Only available data were used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 2 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 4, 4, 3, 8, 11, 15) | 3 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 4, 4, 1, 2, 5, 7) | 3 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 5, 4, 3, 11, 12, 17) | 4 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 4, 4, 1, 2, 5, 7) | 4 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 4, 4, 3, 8, 11, 15) | 4 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 3 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 5, 4, 3, 11, 12, 17) | 4 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 5, 4, 3, 11, 12, 17) | 1 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 4, 4, 1, 2, 5, 7) | 0 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 4, 4, 3, 8, 11, 15) | 2 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 0 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 9 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 5, 4, 3, 11, 12, 17) | 7 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 4, 4, 3, 8, 11, 15) | 5 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 4, 4, 1, 2, 5, 7) | 2 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 4, 4, 1, 2, 5, 7) | 4 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 5, 4, 3, 11, 12, 17) | 7 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 4, 4, 3, 8, 11, 15) | 5 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 7 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 4, 4, 3, 8, 11, 15) | 12 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 4, 4, 1, 2, 5, 7) | 5 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 5, 4, 3, 11, 12, 17) | 14 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 15 Number of participants |
Secondary
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level \<50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.
Time frame: Baseline, Month 6, Month 12 and Last visit
Population: Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ \> 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 2 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 3, 2, 3, 8, 11, 15) | 2 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 3, 3, 1, 2, 5, 7) | 2 Number of participants |
| Participants From A5271015 - Lersivirine 500 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 4, 3, 3, 11, 12, 17) | 3 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 3, 3, 1, 2, 5, 7) | 3 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 3, 2, 3, 8, 11, 15) | 2 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 3 Number of participants |
| Participants From A5271015 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 4, 3, 3, 11, 12, 17) | 3 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 4, 3, 3, 11, 12, 17) | 1 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 3, 3, 1, 2, 5, 7) | 0 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 3, 2, 3, 8, 11, 15) | 2 Number of participants |
| Participants From A5271015 - Efavirenz 600 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 0 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 9 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 4, 3, 3, 11, 12, 17) | 7 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 3, 2, 3, 8, 11, 15) | 5 Number of participants |
| Participants From A5271022 - Lersivirine 750 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 3, 3, 1, 2, 5, 7) | 2 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 3, 3, 1, 2, 5, 7) | 4 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 4, 3, 3, 11, 12, 17) | 7 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 3, 2, 3, 8, 11, 15) | 5 Number of participants |
| Participants From A5271022 - Lersivirine 1000 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 7 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 6 (N = 3, 2, 3, 8, 11, 15) | 12 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Month 12 (N = 3, 3, 1, 2, 5, 7) | 5 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Last Visit (N = 4, 3, 3, 11, 12, 17) | 14 Number of participants |
| Participants From A5271022 - Etravirine 200 mg Arm | Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit | Baseline (N = 5, 4, 3, 11, 12, 17) | 15 Number of participants |