Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Nevirapine XR; Nevirapine XR; Nevirapine IR
Intervention description: Nevirapine XR; Nevirapine extended release; Nevirapine Immediate Release
Intervention MeSH terms: Nevirapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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