The patients for this trial are to be HIV-1 infected, antiretroviral treatment-experienced, currently receiving nevirapine IR 200 mg BID with a background therapy of fixed-dose combination (FDC) of 3TC + ABC, FTC + TDF or 3TC + /AZT, men and women = 18 years of age, with an HIV-1 viral load of = 50 copies/mL.
Conditions
Interventions
Product Name: Nevirapine Tablets, Extended Release, 400 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: NEVIRAPINE
CAS Number: 129618402
Concentration unit: mg milligram(s)
Conce
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion 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 GCP and the local legislation. 2. HIV-1 infected males or females = 18 years. 3. Treatment with Viramune regimen for at least the preceding 18 weeks. 4. Background therapy with 3TC/ABC (Kivexa® in EU; Epzicom in US), FTC/TDF (Truvada™) or 3TC/AZT (Combivir®). 5. An HIV viral load =65 years) yes F.1.3.1 Number of subjects for this age range
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: a. Have a positive serum pregnancy test at screening. b. Are breast feeding. c. Are planning to become pregnant d. Are not willing to use a double-barrier methods (simultaneous use of two diffeent 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 (PT, PTT, INR) • Hematology (absolute platelets, 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 |
|---|---|
| Main Objective: 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.;Secondary Objective: Secondary objective of this study is to assess the safety and tolerance of NVP XR based regimen for HIV-1 infected patients who were receiving NVP IR based regimen for at least 18 prior weeks of therapy. ;Primary end point(s): The primary endpoint is proportion of sustained virologic response through Week 24. The time window of week 24 is defined as 24 weeks ± 4 weeks from Day 1. A patient will be considered as a treatment failure at the earliest time of any one of the following events prior to Week 24: • A virologic failure defined by viral load = 50 copies/mL measured at two consecutive visits, at least two weeks apart. • Change of ARV therapy defined as use of new ARV therapy. • Death. • Lost to follow-up. If the treatment failure is an unconfirmed VL = 50 copies/mL in the Week 24 window, then another measurement two weeks later is necessary to confirm whether a virologic failure has occurred. | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed