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CompletedNCT00819052Updated Nov 10, 2014Results posted

Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients

A Phase 3 interventional study of Nevirapine XR and Nevirapine XR in HIV Infections, sponsored by Boehringer Ingelheim. Completed at 39 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-10.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
445
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 445 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
445 participants (actual)

Study arms

  • Active comparator
    NVP IR

    200 mg orally twice a day (po BID)

    Drug: Nevirapine XR · Drug: Nevirapine IR

  • Experimental
    NVP XR

    400 mg orally once a day (po QD)

    Drug: Nevirapine XR

Interventions

  • DrugNevirapine XR

    Nevirapine XR

  • DrugNevirapine XR

    Nevirapine extended release

  • DrugNevirapine IR

    Nevirapine Immediate Release

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population

    Time frame: week 0

  8. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 2

  9. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 4

  10. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 8

  11. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 12

  12. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 24

  13. Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 24

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 48

  25. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 60

  26. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 72

  27. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 84

  28. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 96

  29. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 108

  30. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 120

  31. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 132

  32. Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population

    Time frame: baseline, week 144

  33. 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)

  34. 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

  35. 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

  36. Changes in Safety Parameters Related to Treatment

    Occurence of investigations related to treatment

    Time frame: until week 144

  37. Occurence of Rashes

    drug-related rashes by severity

    Time frame: 144 weeks

  38. Occurence of Hepatic Events

    Time frame: 144 weeks

  39. New AIDS or AIDS-related Progression Event or Death

    Time frame: 144 weeks

  40. 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

  41. 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

  42. 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

07

Results

Posted Feb 24, 2012

Participant flow

Participant flow — Overall Study
MilestoneNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Started148295
Completed142281
Not completed614
Withdrew: Adverse event05
Withdrew: Protocol violation12
Withdrew: Lost to follow-up12
Withdrew: Withdrawal by subject12
Withdrew: Lack of efficacy11
Withdrew: Pregnancy12
Withdrew: Death or events leading to death10

Outcome measures

PrimaryComparison 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
Reported as:
Number · participants
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Responder137276
Non responder1119
Statistical analysis
  • Nevirapine Immediate Release (NVP IR) vs Nevirapine Extended Release (NVP XR) · Cochran's statistic · Cochran's statistic: 1.0 · 95% CI -4.3 to 6.2Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Responder148292
Non responder03
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Responder146291
Non responder24
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Responder146290
Non responder25
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Responder143289
Non responder56
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Responder140285
Non responder810
SecondaryKaplan-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
Reported as:
Number · proportion of participants
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
proportion of participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Interval Week 0 to <211
Interval Week 2 to <410.986
Interval Week 4 to <80.9930.98
Interval Week 8 to <120.9730.973
Interval Week 12 to <160.9590.966
Interval Week 16 to <200.9460.953
Interval Week 20 to <240.9460.946
Interval Week 24 to <280.9460.942
SecondarySummary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population
Time frame:
week 0
Reported as:
Mean · cells/cubic millimeter
Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population569.7 ± 215.6557.7 ± 213.2
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 2
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population3.7 ± 115.2-4.7 ± 107.7
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 4
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population0.8 ± 110.8-15.4 ± 114.1
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 8
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population-18.6 ± 122.9-24.4 ± 117.6
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 12
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population22.3 ± 152.9-10.2 ± 118.5
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 24
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population50.4 ± 162.845.7 ± 137.6
SecondaryComparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 24
Reported as:
Least squares mean · cells/cubic millimeter
Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population50.74 ± 12.707246.10 ± 9.2053
Statistical analysis
  • Nevirapine Immediate Release (NVP IR) vs Nevirapine Extended Release (NVP XR) · ANCOVA · p = 0.7587 · Mean difference (final values): -4.64 · 95% CI -34.34 to 25.05Means adjusted for background ARV (Antiretroviral) stratum
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder12511268
Non responder518
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1229253
Non responder8321
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1249265
Non responder606
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1187244
Non responder7124
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1179242
Non responder7021
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1198247
Non responder6113
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1127235
Non responder9123
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1156238
Non responder6114
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1157238
Non responder6012
SecondaryNumber 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
Reported as:
Number · participants
Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder12111261
Non responder9215
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 48
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population77.8 ± 142.8139.8 ± 126.952.7 ± 143.5
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 60
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population51.1 ± 138.111.5 ± 138.455.1 ± 136.5
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 72
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population61.3 ± 128.677.9 ± 109.567.4 ± 141.5
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 84
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population80.3 ± 156.5134.6 ± 214.255.0 ± 130.9
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 96
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population55.1 ± 156.755.4 ± 80.760.2 ± 130.3
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 108
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population72.4 ± 160.4117.4 ± 151.373.5 ± 151.0
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 120
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population79.5 ± 168.490.0 ± 151.066.6 ± 182.3
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 132
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population58.8 ± 153.6124.8 ± 158.770.8 ± 146.7
SecondaryChange From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population
Time frame:
baseline, week 144
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population85.3 ± 151.6205.6 ± 388.682.7 ± 157.4
SecondaryChange 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)
Reported as:
Mean · cells/cubic millimeter
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population
cells/cubic millimeterNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population71.9 ± 157.1165.9 ± 302.580.9 ± 163.5
SecondaryProportion 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
Reported as:
Number · participants
Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144
participantsNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
Responder1217250
No Responder000
SecondaryChange 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
Reported as:
Mean · copies/mL
Change From Baseline in VL (HIV-1 Viral Load) at Each Visit
copies/mLNevirapine (NVP) IR / NVP XRNevirapine IR After Week 48Nevirapine XR After Week 48
week 48 (N=130, 12, 275)48.4 ± 536.958.4 ± 202.3-4.3 ± 67.6
week 60 (N=130, 12, 274)11004.4 ± 12541594.1 ± 218.5-1.8 ± 69.4
week 72 (N=129, 9, 271)1747.0 ± 198060.0 ± 0.0-4.9 ± 68.2
week 84 (N=125, 8, 268)2798.8 ± 313014.1 ± 11.74140.1 ± 67801
week 96 (N=124, 9, 263)0.2 ± 17.70.0 ± 0.0168.4 ± 1974.7
week 108 (N=125, 8, 260)53.1 ± 574.20.0 ± 0.0-3.5 ± 70.6
week 120 (N=121, 8, 257)3.5 ± 42.70.4 ± 1.1-2.3 ± 71.0
week 132 (121, 7, 252)10.2 ± 78.74.0 ± 10.6-1.8 ± 79.0
week 144 (N=121, 7, 250)1.0 ± 24.50.0 ± 0.0-4.6 ± 70.9
last available visit(N=130,13,276)4472.6 ± 3635786.4 ± 211.04103.2 ± 66822
SecondaryChanges in Safety Parameters Related to Treatment

Occurence of investigations related to treatment

Time frame:
until week 144
Reported as:
Number · participants
Changes in Safety Parameters Related to Treatment
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Alanine aminotransferase increased14
Aspartate aminotransferase increased02
Blood amylase increased10
Blood triglycerides increased10
Gamma-glutamyltransferase increased02
Lipase increased10
Liver function test abnormal10
Blood glucose increased01
Blood lacate dehydrogenase increased01
Neutrophil count decreased01
Transaminases increased01
SecondaryOccurence of Rashes

drug-related rashes by severity

Time frame:
144 weeks
Reported as:
Number · participants
Occurence of Rashes
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
rash Grade 1 mild01
rash Grade 2 moderate01
rash Grade 3 severe00
rash Grade 4 potential life-threatening00
SecondaryOccurence of Hepatic Events
Time frame:
144 weeks
Reported as:
Number · participants
Occurence of Hepatic Events
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Occurence of Hepatic Events01
SecondaryNew AIDS or AIDS-related Progression Event or Death
Time frame:
144 weeks
Reported as:
Number · participants
New AIDS or AIDS-related Progression Event or Death
participantsNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
new AIDS or AIDS related progression12
death22
SecondaryTime 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
Reported as:
Median · days
Time to Loss of Virologic Response
daysNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Time to Loss of Virologic Response393 (393 to 406)391 (377 to 423)
SecondaryGenotypic 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

No measurements were reported for this outcome.

SecondaryTrough 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
Reported as:
Geometric mean · ng/mL
Trough Plasma Concentration
ng/mLNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Day 1 (N=146, 0)3720 ± 65.4NA ± NA
Week 2 (N=107, 229)3650 ± 38.13270 ± 57.6
Week 4 (N=103, 234)3720 ± 36.63230 ± 49.0
Week 8 (N=110, 225)4080 ± 38.23650 ± 46.1
Week 12 (N=103, 223)4170 ± 41.13590 ± 50.2
Week 24 (N=103, 212)4080 ± 36.93750 ± 41.8
Week 36 (N=103, 215)4370 ± 40.63930 ± 41.5
Week 48 (N=101, 213)3960 ± 41.83650 ± 45.0

Adverse events

Collected over 144 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nevirapine Immediate Release (NVP IR)—33/148 (22.3%)110/148 (74.3%)
Nevirapine Extended Release (NVP XR)—73/295 (24.7%)244/295 (82.7%)
Most frequent serious events
Showing 10 of 126
Most frequent serious events
EventNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)4/1483/295
DepressionPsychiatric disorders3/1481/295
Chest painGeneral disorders2/1481/295
PneumoniaInfections and infestations2/1483/295
Myocardial infarctionCardiac disorders0/1483/295
Coronary artery stenosisCardiac disorders0/1482/295
Anal fissureGastrointestinal disorders1/1482/295
HaemorrhoidsGastrointestinal disorders1/1482/295
Inguinal herniaGastrointestinal disorders1/1482/295
BronchitisInfections and infestations1/1482/295
Most frequent other events
Showing 10 of 25
Most frequent other events
EventNevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)
NasopharyngitisInfections and infestations25/14874/295
DiarrhoeaGastrointestinal disorders20/14862/295
BronchitisInfections and infestations24/14849/295
Upper respiratory tract infectionInfections and infestations21/14835/295
Back painMusculoskeletal and connective tissue disorders20/14840/295
SinusitisInfections and infestations20/14833/295
CoughRespiratory, thoracic and mediastinal disorders18/14836/295
DepressionPsychiatric disorders10/14833/295
HeadacheNervous system disorders13/14831/295
FatigueGeneral disorders9/14830/295

Baseline characteristics

Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment

Age, Continuous
Age, Continuous(years)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
Mean47.6 ± 9.847.3 ± 9.647.4 ± 9.7
Age, Customized
Age, Customized(participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
18 to < 41 years3670106
41 to < 56 years79168247
56 to < 65 years243862
65 years or more91928
Sex: Female, Male
Sex: Female, Male(Participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
Female204969
Male128246374
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
Asian055
Black142034
White134270404
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
Hispanic / Latino132269401
Not Hispanic / Latino162642
Region of Enrollment
Region of Enrollment(participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
North America4698144
Europe102197299
Smoking History
Smoking History(participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
Never smoked68131199
Ex-smoker3767104
Current smoker4397140
Alcohol Status
Alcohol Status(participants)Nevirapine Immediate Release (NVP IR)Nevirapine Extended Release (NVP XR)Total
Non drinker4475119
Drinks - no interfere with trial103214317
Drinks - could interfere with trial167
08

Study locations

39 sites
  • 1100.1526.1012 Boehringer Ingelheim Investigational Site
    Beverly Hills, California, United States
  • 1100.1526.1014 Boehringer Ingelheim Investigational Site
    Beverly Hills, California, United States
  • 1100.1526.1011 Boehringer Ingelheim Investigational Site
    Long Beach, California, United States
  • 1100.1526.1013 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
  • 1100.1526.1001 Boehringer Ingelheim Investigational Site
    Washington, District of Columbia, United States
  • 1100.1526.1004 Boehringer Ingelheim Investigational Site
    Washington, District of Columbia, United States
  • 1100.1526.1006 Boehringer Ingelheim Investigational Site
    Clearwater, Florida, United States
  • 1100.1526.1005 Boehringer Ingelheim Investigational Site
    Miami Beach, Florida, United States
  • 1100.1526.1002 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
  • 1100.1526.1003 Boehringer Ingelheim Investigational Site
    Berkley, Michigan, United States
  • 1100.1526.1007 Boehringer Ingelheim Investigational Site
    Austin, Texas, United States
  • 1100.1526.3306A Boehringer Ingelheim Investigational Site
    Bobigny, France
  • 1100.1526.3311A Boehringer Ingelheim Investigational Site
    Bordeaux, France
  • 1100.1526.3307A Boehringer Ingelheim Investigational Site
    La Roche sur Yon, France
  • 1100.1526.3312A Boehringer Ingelheim Investigational Site
    Le Kremlin-Bicêtre Cedex, France
  • 1100.1526.3301A Boehringer Ingelheim Investigational Site
    Lyon Cedex 3, France
  • 1100.1526.3310A Boehringer Ingelheim Investigational Site
    Marseille cedex 9, France
  • 1100.1526.3308A Boehringer Ingelheim Investigational Site
    Montpellier cedex 5, France
  • 1100.1526.3302A Boehringer Ingelheim Investigational Site
    Nantes, France
  • 1100.1526.3304A Boehringer Ingelheim Investigational Site
    Nice cedex 3, France
  • 1100.1526.4902 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 1100.1526.4903 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 1100.1526.4904 Boehringer Ingelheim Investigational Site
    Bochum, Germany
  • 1100.1526.4905 Boehringer Ingelheim Investigational Site
    Bonn, Germany
  • 1100.1526.4906 Boehringer Ingelheim Investigational Site
    Düsseldorf, Germany
  • 1100.1526.4908 Boehringer Ingelheim Investigational Site
    Frankfurt/Main, Germany
  • 1100.1526.4909 Boehringer Ingelheim Investigational Site
    Frankfurt, Germany
  • 1100.1526.4901 Boehringer Ingelheim Investigational Site
    Freiburg, Germany
  • 1100.1526.4910 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1100.1526.4911 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1100.1526.4912 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1100.1526.4913 Boehringer Ingelheim Investigational Site
    Hannover, Germany
  • 1100.1526.4907 Boehringer Ingelheim Investigational Site
    Köln, Germany
  • 1100.1526.4914 Boehringer Ingelheim Investigational Site
    Köln, Germany
  • 1100.1526.4915 Boehringer Ingelheim Investigational Site
    München, Germany
  • 1100.1526.4403 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 1100.1526.4405 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 1100.1526.4404 Boehringer Ingelheim Investigational Site
    Manchester, United Kingdom
  • 1100.1526.4402 Boehringer Ingelheim Investigational Site
    Tooting, London, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00819052
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jan 8, 2009
Start date
Dec 2008
Primary completion
Jan 2012
Completion
Jan 2012
Results posted
Feb 24, 2012
Last update
Nov 10, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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