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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00819052
• Date of registration: 07/01/2009
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
• Scientific title: An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program
• Date of first enrolment: December 2008
• Target sample size: 445
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00819052
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France, Germany, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Nevirapine IR

Drug: Nevirapine XR

Primary Outcome(s)

Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 24]

Secondary Outcome(s)

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 144]

Genotypic Resistance Associated With Virologic Failure [Time Frame: 48 weeks]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [Time Frame: week 2]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 96]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 12]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 4]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 60]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 84]

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)]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [Time Frame: week 4]

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]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 8]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 84]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 120]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 96]

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]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 24]

Changes in Safety Parameters Related to Treatment [Time Frame: until week 144]

Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 24]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 132]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: last available visit, up to 144 weeks]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 2]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 132]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 48]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 144]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 108]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 72]

Trough Plasma Concentration [Time Frame: Day 1 to week 48]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 72]

New AIDS or AIDS-related Progression Event or Death [Time Frame: 144 weeks]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [Time Frame: week 12]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [Time Frame: week 8]

Occurence of Hepatic Events [Time Frame: 144 weeks]

Occurence of Rashes [Time Frame: 144 weeks]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 120]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 48]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population [Time Frame: week 60]

Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 [Time Frame: week 144]

Time to Loss of Virologic Response [Time Frame: 48 weeks]

Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population [Time Frame: baseline, week 108]

Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population [Time Frame: week 24]

Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population [Time Frame: week 0]

Secondary ID(s)

1100.1526

2008-004681-55

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00819052