HIV Infections
Conditions
Brief summary
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
Interventions
DRUGNevirapine XR
Nevirapine XR
DRUGNevirapine IR
Nevirapine Immediate Release
Sponsors
Boehringer Ingelheim
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
HIV infected subjects treated with a Viramune based regimen. A subject that meets the following inclusion criteria will be eligible for participation in this study: 1. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation. 2. HIV-1 infected males or females of at least 18 years. 3. Treatment with Viramune regimen for at least the preceding 18 weeks. 4. Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®). 5. An HIV viral load \< 50 copies/mL in preceding 3 months. 6. An HIV viral load of \< 50 copies/mL at screening (Visit 1). 7. Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions: alanine aminotrnasferase (ALT) and asparatate aminotransferase (AST) \< 2.5 × upper limit of normal (ULN) Division of Acquired Immunodeficiency Syndrome (DAIDS Grade 1). 8. Willingness to abstain from ingesting medications that are listed as contraindicated in the Summary of Product Characteristics (SPC) or package insert (or PI) or Investigator's Brochure during the study. 9. Karnofsky performance score of \< 70
Exclusion criteria
Subjects who meet one or more of the following criteria will be excluded from the study: 1. Current treatment with an HIV protease inhibitor 2. Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study 3. Female patients of child-bearing potential who: 1. Have a positive serum pregnancy test at screening. 2. Are breast feeding. 3. Are planning to become pregnant 4. Are not willing to use a double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.. 4. Laboratory parameters \> DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase) 5. Laboratory parameters \> DAIDS grade 3 Total triglycerides (total cholesterol no restriction) 6. Hypersensitivity to any ingredients of the test products 7. Active drug abuse or chronic alcoholism. 8. Hepatic cirrhosis stage Child-Pugh B or C 9. History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial 10. Inability to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 24 | Primary endpoint was the number of patients with a sustained virologic response through week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population | week 0 | — |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | week 2 | Endpoint was the number of patients with a sustained virologic response through week 2 |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population | baseline, week 2 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population | baseline, week 4 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population | baseline, week 8 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population | baseline, week 12 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population | baseline, week 24 | — |
| Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population | baseline, week 24 | — |
| Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 48 | Endpoint was the number of patients with a sustained virologic response through week 48 |
| Changes in Safety Parameters Related to Treatment | until week 144 | Occurence of investigations related to treatment |
| Occurence of Rashes | 144 weeks | drug-related rashes by severity |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population | baseline, week 48 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population | baseline, week 60 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population | baseline, week 72 | — |
| Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | week 0 to 24 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population | baseline, week 96 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population | baseline, week 108 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population | baseline, week 120 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population | baseline, week 132 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population | baseline, week 144 | — |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population | baseline, last available visit (up to 144 weeks) | — |
| Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | week 144 | Endpoint was the number of patients with a sustained virologic response through week 144 |
| Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit | — |
| Occurence of Hepatic Events | 144 weeks | — |
| New AIDS or AIDS-related Progression Event or Death | 144 weeks | — |
| Time to Loss of Virologic Response | 48 weeks | Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks. |
| Genotypic Resistance Associated With Virologic Failure | 48 weeks | Genotypic resistance associated with virologic failure. This endpoint was not analysed due to lack of data. |
| Trough Plasma Concentration | Day 1 to week 48 | Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9). |
| Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population | baseline, week 84 | — |
Countries
France, Germany, United Kingdom, United States
Participant flow
Pre-assignment details
Two patients were randomized, but have not been treated. They were excluded from the treated set.
Participants by arm
| Arm | Count |
|---|---|
| Nevirapine Immediate Release (NVP IR) Nevirapine immediate release 200 mg tablets given twice daily | 148 |
| Nevirapine Extended Release (NVP XR) Nevirapine extended release 400 mg tablets given once daily | 295 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 5 |
| Overall Study | Death or events leading to death | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Pregnancy | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Nevirapine Immediate Release (NVP IR) | Nevirapine Extended Release (NVP XR) | Total |
|---|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 9.8 | 47.3 years STANDARD_DEVIATION 9.6 | 47.4 years STANDARD_DEVIATION 9.7 |
| Age, Customized 18 to < 41 years | 36 participants | 70 participants | 106 participants |
| Age, Customized 41 to < 56 years | 79 participants | 168 participants | 247 participants |
| Age, Customized 56 to < 65 years | 24 participants | 38 participants | 62 participants |
| Age, Customized 65 years or more | 9 participants | 19 participants | 28 participants |
| Alcohol Status Drinks - could interfere with trial | 1 participants | 6 participants | 7 participants |
| Alcohol Status Drinks - no interfere with trial | 103 participants | 214 participants | 317 participants |
| Alcohol Status Non drinker | 44 participants | 75 participants | 119 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 5 participants | 5 participants |
| Race/Ethnicity, Customized Black | 14 participants | 20 participants | 34 participants |
| Race/Ethnicity, Customized Hispanic / Latino | 132 Participants | 269 Participants | 401 Participants |
| Race/Ethnicity, Customized Not Hispanic / Latino | 16 Participants | 26 Participants | 42 Participants |
| Race/Ethnicity, Customized White | 134 participants | 270 participants | 404 participants |
| Region of Enrollment Europe | 102 participants | 197 participants | 299 participants |
| Region of Enrollment North America | 46 participants | 98 participants | 144 participants |
| Sex: Female, Male Female | 20 Participants | 49 Participants | 69 Participants |
| Sex: Female, Male Male | 128 Participants | 246 Participants | 374 Participants |
| Smoking History Current smoker | 43 participants | 97 participants | 140 participants |
| Smoking History Ex-smoker | 37 participants | 67 participants | 104 participants |
| Smoking History Never smoked | 68 participants | 131 participants | 199 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 110 / 148 | 244 / 295 |
| serious Total, serious adverse events | 33 / 148 | 73 / 295 |
Outcome results
Primary
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Primary endpoint was the number of patients with a sustained virologic response through week 24
Time frame: week 24
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 137 participants |
| Nevirapine Immediate Release (NVP IR) | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 11 participants |
| Nevirapine Extended Release (NVP XR) | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 276 participants |
| Nevirapine Extended Release (NVP XR) | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 19 participants |
95% CI: [-4.3, 6.2]Cochran's statistic
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population
Time frame: baseline, last available visit (up to 144 weeks)
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population | 71.9 cells/cubic millimeter | Standard Deviation 157.1 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population | 165.9 cells/cubic millimeter | Standard Deviation 302.5 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population | 80.9 cells/cubic millimeter | Standard Deviation 163.5 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 108
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population | 72.4 cells/cubic millimeter | Standard Deviation 160.4 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population | 117.4 cells/cubic millimeter | Standard Deviation 151.3 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population | 73.5 cells/cubic millimeter | Standard Deviation 151 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 120
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population | 79.5 cells/cubic millimeter | Standard Deviation 168.4 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population | 90.0 cells/cubic millimeter | Standard Deviation 151 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population | 66.6 cells/cubic millimeter | Standard Deviation 182.3 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 12
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population | 22.3 cells/cubic millimeter | Standard Deviation 152.9 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population | -10.2 cells/cubic millimeter | Standard Deviation 118.5 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 132
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population | 58.8 cells/cubic millimeter | Standard Deviation 153.6 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population | 124.8 cells/cubic millimeter | Standard Deviation 158.7 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population | 70.8 cells/cubic millimeter | Standard Deviation 146.7 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 144
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population | 85.3 cells/cubic millimeter | Standard Deviation 151.6 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population | 205.6 cells/cubic millimeter | Standard Deviation 388.6 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population | 82.7 cells/cubic millimeter | Standard Deviation 157.4 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 24
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population | 50.4 cells/cubic millimeter | Standard Deviation 162.8 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population | 45.7 cells/cubic millimeter | Standard Deviation 137.6 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 2
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population | 3.7 cells/cubic millimeter | Standard Deviation 115.2 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population | -4.7 cells/cubic millimeter | Standard Deviation 107.7 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 48
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population | 77.8 cells/cubic millimeter | Standard Deviation 142.8 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population | 139.8 cells/cubic millimeter | Standard Deviation 126.9 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population | 52.7 cells/cubic millimeter | Standard Deviation 143.5 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 4
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population | 0.8 cells/cubic millimeter | Standard Deviation 110.8 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population | -15.4 cells/cubic millimeter | Standard Deviation 114.1 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 60
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population | 51.1 cells/cubic millimeter | Standard Deviation 138.1 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population | 11.5 cells/cubic millimeter | Standard Deviation 138.4 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population | 55.1 cells/cubic millimeter | Standard Deviation 136.5 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 72
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population | 61.3 cells/cubic millimeter | Standard Deviation 128.6 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population | 77.9 cells/cubic millimeter | Standard Deviation 109.5 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population | 67.4 cells/cubic millimeter | Standard Deviation 141.5 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 84
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population | 80.3 cells/cubic millimeter | Standard Deviation 156.5 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population | 134.6 cells/cubic millimeter | Standard Deviation 214.2 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population | 55.0 cells/cubic millimeter | Standard Deviation 130.9 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 8
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population | -18.6 cells/cubic millimeter | Standard Deviation 122.9 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population | -24.4 cells/cubic millimeter | Standard Deviation 117.6 |
Secondary
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 96
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population | 55.1 cells/cubic millimeter | Standard Deviation 156.7 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population | 55.4 cells/cubic millimeter | Standard Deviation 80.7 |
| Nevirapine XR After Week 48 | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population | 60.2 cells/cubic millimeter | Standard Deviation 130.3 |
Secondary
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
Time frame: week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 84 (N=125, 8, 268) | 2798.8 copies/mL | Standard Deviation 31301 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 132 (121, 7, 252) | 10.2 copies/mL | Standard Deviation 78.7 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 60 (N=130, 12, 274) | 11004.4 copies/mL | Standard Deviation 125415 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 96 (N=124, 9, 263) | 0.2 copies/mL | Standard Deviation 17.7 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 72 (N=129, 9, 271) | 1747.0 copies/mL | Standard Deviation 19806 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 108 (N=125, 8, 260) | 53.1 copies/mL | Standard Deviation 574.2 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | last available visit(N=130,13,276) | 4472.6 copies/mL | Standard Deviation 36357 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 144 (N=121, 7, 250) | 1.0 copies/mL | Standard Deviation 24.5 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 120 (N=121, 8, 257) | 3.5 copies/mL | Standard Deviation 42.7 |
| Nevirapine Immediate Release (NVP IR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 48 (N=130, 12, 275) | 48.4 copies/mL | Standard Deviation 536.9 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 120 (N=121, 8, 257) | 0.4 copies/mL | Standard Deviation 1.1 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 132 (121, 7, 252) | 4.0 copies/mL | Standard Deviation 10.6 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 144 (N=121, 7, 250) | 0.0 copies/mL | Standard Deviation 0 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 72 (N=129, 9, 271) | 0.0 copies/mL | Standard Deviation 0 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | last available visit(N=130,13,276) | 86.4 copies/mL | Standard Deviation 211 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 84 (N=125, 8, 268) | 4.1 copies/mL | Standard Deviation 11.7 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 96 (N=124, 9, 263) | 0.0 copies/mL | Standard Deviation 0 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 108 (N=125, 8, 260) | 0.0 copies/mL | Standard Deviation 0 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 60 (N=130, 12, 274) | 94.1 copies/mL | Standard Deviation 218.5 |
| Nevirapine Extended Release (NVP XR) | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 48 (N=130, 12, 275) | 58.4 copies/mL | Standard Deviation 202.3 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | last available visit(N=130,13,276) | 4103.2 copies/mL | Standard Deviation 66822 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 48 (N=130, 12, 275) | -4.3 copies/mL | Standard Deviation 67.6 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 60 (N=130, 12, 274) | -1.8 copies/mL | Standard Deviation 69.4 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 72 (N=129, 9, 271) | -4.9 copies/mL | Standard Deviation 68.2 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 84 (N=125, 8, 268) | 4140.1 copies/mL | Standard Deviation 67801 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 108 (N=125, 8, 260) | -3.5 copies/mL | Standard Deviation 70.6 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 120 (N=121, 8, 257) | -2.3 copies/mL | Standard Deviation 71 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 132 (121, 7, 252) | -1.8 copies/mL | Standard Deviation 79 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 144 (N=121, 7, 250) | -4.6 copies/mL | Standard Deviation 70.9 |
| Nevirapine XR After Week 48 | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | week 96 (N=124, 9, 263) | 168.4 copies/mL | Standard Deviation 1974.7 |
Secondary
Changes in Safety Parameters Related to Treatment
Occurence of investigations related to treatment
Time frame: until week 144
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Blood triglycerides increased | 1 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Liver function test abnormal | 1 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Blood amylase increased | 1 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Blood glucose increased | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Gamma-glutamyltransferase increased | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Blood lacate dehydrogenase increased | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Aspartate aminotransferase increased | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Neutrophil count decreased | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Lipase increased | 1 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Transaminases increased | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Changes in Safety Parameters Related to Treatment | Alanine aminotransferase increased | 1 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Transaminases increased | 1 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Alanine aminotransferase increased | 4 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Aspartate aminotransferase increased | 2 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Blood amylase increased | 0 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Blood triglycerides increased | 0 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Gamma-glutamyltransferase increased | 2 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Lipase increased | 0 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Liver function test abnormal | 0 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Blood glucose increased | 1 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Blood lacate dehydrogenase increased | 1 participants |
| Nevirapine Extended Release (NVP XR) | Changes in Safety Parameters Related to Treatment | Neutrophil count decreased | 1 participants |
Secondary
Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population
Time frame: baseline, week 24
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population | 50.74 cells/cubic millimeter | Standard Error 12.7072 |
| Nevirapine Extended Release (NVP XR) | Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population | 46.10 cells/cubic millimeter | Standard Error 9.2053 |
p-value: 0.758795% CI: [-34.34, 25.05]ANCOVA
Secondary
Genotypic Resistance Associated With Virologic Failure
Genotypic resistance associated with virologic failure. This endpoint was not analysed due to lack of data.
Time frame: 48 weeks
Population: All patients in the treated set who experienced virologic failure.
Secondary
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time frame: week 0 to 24
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 0 to <2 | 1 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 2 to <4 | 1 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 4 to <8 | 0.993 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 8 to <12 | 0.973 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 12 to <16 | 0.959 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 16 to <20 | 0.946 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 20 to <24 | 0.946 proportion of participants |
| Nevirapine Immediate Release (NVP IR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 24 to <28 | 0.946 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 24 to <28 | 0.942 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 0 to <2 | 1 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 12 to <16 | 0.966 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 2 to <4 | 0.986 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 20 to <24 | 0.946 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 4 to <8 | 0.98 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 16 to <20 | 0.953 proportion of participants |
| Nevirapine Extended Release (NVP XR) | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Interval Week 8 to <12 | 0.973 proportion of participants |
Secondary
New AIDS or AIDS-related Progression Event or Death
Time frame: 144 weeks
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | New AIDS or AIDS-related Progression Event or Death | new AIDS or AIDS related progression | 1 participants |
| Nevirapine Immediate Release (NVP IR) | New AIDS or AIDS-related Progression Event or Death | death | 2 participants |
| Nevirapine Extended Release (NVP XR) | New AIDS or AIDS-related Progression Event or Death | new AIDS or AIDS related progression | 2 participants |
| Nevirapine Extended Release (NVP XR) | New AIDS or AIDS-related Progression Event or Death | death | 2 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 8
Time frame: week 8
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 146 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 2 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 290 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 5 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 24
Time frame: week 24
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 140 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 8 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 285 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 10 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 2
Time frame: week 2
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 148 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 0 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 292 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 3 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 4
Time frame: week 4
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 146 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 2 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 291 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 4 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 12
Time frame: week 12
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 143 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 5 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Responder | 289 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Non responder | 6 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 120
Time frame: week 120
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 112 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 9 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 7 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 1 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 235 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 23 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 48
Time frame: week 48
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 125 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 5 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 11 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 1 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 268 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 8 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 60
Time frame: week 60
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 122 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 8 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 9 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 3 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 253 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 21 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 72
Time frame: week 72
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 124 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 6 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 9 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 0 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 265 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 6 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 84
Time frame: week 84
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 118 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 7 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 7 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 1 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 244 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 24 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 96
Time frame: week 96
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 117 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 7 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 9 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 0 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 242 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 21 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 108
Time frame: week 108
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 119 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 6 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 8 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 1 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 247 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 13 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 132
Time frame: week 132
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 115 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 6 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 6 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 1 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 238 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 14 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response through week 144
Time frame: week 144
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 115 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 6 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 7 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 0 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 238 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 12 participants |
Secondary
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Endpoint was the number of patients with a sustained virologic response at their last available visit
Time frame: last available visit, up to 144 weeks
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 121 participants |
| Nevirapine Immediate Release (NVP IR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 9 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 11 participants |
| Nevirapine Extended Release (NVP XR) | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 2 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Responder | 261 participants |
| Nevirapine XR After Week 48 | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Non responder | 15 participants |
Secondary
Occurence of Hepatic Events
Time frame: 144 weeks
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Occurence of Hepatic Events | 0 participants |
| Nevirapine Extended Release (NVP XR) | Occurence of Hepatic Events | 1 participants |
Secondary
Occurence of Rashes
drug-related rashes by severity
Time frame: 144 weeks
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Occurence of Rashes | rash Grade 2 moderate | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Occurence of Rashes | rash Grade 1 mild | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Occurence of Rashes | rash Grade 3 severe | 0 participants |
| Nevirapine Immediate Release (NVP IR) | Occurence of Rashes | rash Grade 4 potential life-threatening | 0 participants |
| Nevirapine Extended Release (NVP XR) | Occurence of Rashes | rash Grade 4 potential life-threatening | 0 participants |
| Nevirapine Extended Release (NVP XR) | Occurence of Rashes | rash Grade 1 mild | 1 participants |
| Nevirapine Extended Release (NVP XR) | Occurence of Rashes | rash Grade 2 moderate | 1 participants |
| Nevirapine Extended Release (NVP XR) | Occurence of Rashes | rash Grade 3 severe | 0 participants |
Secondary
Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144
Endpoint was the number of patients with a sustained virologic response through week 144
Time frame: week 144
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | Responder | 121 participants |
| Nevirapine Immediate Release (NVP IR) | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | No Responder | 0 participants |
| Nevirapine Extended Release (NVP XR) | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | Responder | 7 participants |
| Nevirapine Extended Release (NVP XR) | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | No Responder | 0 participants |
| Nevirapine XR After Week 48 | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | Responder | 250 participants |
| Nevirapine XR After Week 48 | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | No Responder | 0 participants |
Secondary
Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population
Time frame: week 0
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population | 569.7 cells/cubic millimeter | Standard Deviation 215.6 |
| Nevirapine Extended Release (NVP XR) | Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population | 557.7 cells/cubic millimeter | Standard Deviation 213.2 |
Secondary
Time to Loss of Virologic Response
Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.
Time frame: 48 weeks
Population: Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Time to Loss of Virologic Response | 393 days |
| Nevirapine Extended Release (NVP XR) | Time to Loss of Virologic Response | 391 days |
Secondary
Trough Plasma Concentration
Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).
Time frame: Day 1 to week 48
Population: All patients with evaluable PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Day 1 (N=146, 0) | 3720 ng/mL | Geometric Coefficient of Variation 65.4 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 2 (N=107, 229) | 3650 ng/mL | Geometric Coefficient of Variation 38.1 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 4 (N=103, 234) | 3720 ng/mL | Geometric Coefficient of Variation 36.6 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 8 (N=110, 225) | 4080 ng/mL | Geometric Coefficient of Variation 38.2 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 12 (N=103, 223) | 4170 ng/mL | Geometric Coefficient of Variation 41.1 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 24 (N=103, 212) | 4080 ng/mL | Geometric Coefficient of Variation 36.9 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 36 (N=103, 215) | 4370 ng/mL | Geometric Coefficient of Variation 40.6 |
| Nevirapine Immediate Release (NVP IR) | Trough Plasma Concentration | Week 48 (N=101, 213) | 3960 ng/mL | Geometric Coefficient of Variation 41.8 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 48 (N=101, 213) | 3650 ng/mL | Geometric Coefficient of Variation 45 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Day 1 (N=146, 0) | NA ng/mL | — |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 12 (N=103, 223) | 3590 ng/mL | Geometric Coefficient of Variation 50.2 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 2 (N=107, 229) | 3270 ng/mL | Geometric Coefficient of Variation 57.6 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 36 (N=103, 215) | 3930 ng/mL | Geometric Coefficient of Variation 41.5 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 4 (N=103, 234) | 3230 ng/mL | Geometric Coefficient of Variation 49 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 24 (N=103, 212) | 3750 ng/mL | Geometric Coefficient of Variation 41.8 |
| Nevirapine Extended Release (NVP XR) | Trough Plasma Concentration | Week 8 (N=110, 225) | 3650 ng/mL | Geometric Coefficient of Variation 46.1 |