This randomised, controlled, open-label trial will be conducted in HIV-1-infected patients who have received no previous antiretroviral treatment (of more than 7 days in total). MedDRA version: 8.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Viramune 200 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: NEVIRAPINE
CAS Number: 129618402
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation 2.HIV-1-infected males or females = 18 years of age with positive serology (ELISA) confirmed by Western blot 3.No previous antiretroviral treatment (of more than 7 days) 4.Males with CD4+ counts of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Active drug abuse or chronic alcoholism at the investigator’s discretion 2.Hepatic cirrhosis stage Child-Pugh B or C 3.Female patients of child-bearing potential who: •have a positive serum pregnancy test at screening or during the study, •are breast feeding, •are planning to become pregnant, •are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives 4.Laboratory parameters > DAIDS grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions) 5.Active hepatitis B or C disease, defined as HBsAg-positive or HCV-RNA-positive with AST/ALT > 2.5x ULN (DAIDS grade 1) 6.Hypersensitivity to any ingredients of the test products 7. (TRIAL PROTOCOL AMENDMENT 4) 8.Patients who are receiving other concomitant treatments which are not permitted, as listed in Appendix 10.6 of the protocol 9.Use of other investigational medications within 30 days before study entry or during the trial 10.Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone) 11.Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma 12.Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit 13.Patients who are receiving systemic treatment for malignant disease 14.Patients who in the opinion of the investigator are not candidates for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this clinical trial is to compare the efficacy and safety of RTV-boosted atazanavir with nevirapine in two different dosing schedules, each on a background of emtricitabine and tenofovir DF.;Secondary Objective: •Change in fasting plasma levels of total cholesterol and in its fractions (HDLC and LDLC), the TC : HDLC ratio, in apolipoprotein A1 and B, hsCRP and total triglyceride levels from baseline to after 48, 96 and 144 weeks of treatment •Change in the estimated cardiovascular risk using the Framingham algorithm of the patients in each treatment group from baseline to after 48, 96 and 144 weeks of treatment •Change in quality of life from baseline to after 24, 48, 96 and 144 weeks of treatment •Cost-effectiveness of each treatment regimen in the time periods from baseline to after 24, 48, 96 and 144 weeks of treatment ;Primary end point(s): The primary endpoint is the treatment response (TR) at Week 48. TR is defined as HIV viral load of < 50 copies/ml measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. If the VL is = 50 copies/ml at Week 48 and this is the first sequential VL value = 50 copies/ml following treatment response, then another measurement at least 2 weeks later is necessary to determine whether rebound has occurred. A rebound is defined by two consecutive measurements of VL = 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL < 50 copies/ml. A change of ARV therapy is either defined as: •A permanent discontinuation of study drug or its control •A change in the dose of ATZ or RTV A change from NVP once daily to twice daily administration and vice versa is not considered failure for the primary analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. | — |
Countries
Germany, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed