None listed
Conditions
Interventions
Prolonged-release nevirapine (XR) Dosage: 400 mg 1 tablet 1 time per day from Day 15 to Week 48 (maximum up to week 144)
Group name:Group 2 Type of group
Nevirapine immediate release (IR) Dosage: 200 mg 1 tablet 2 times per day from Day 15 to Week 48 (maximum up to week 144)
Group 1 Type of group
Sponsors
BOEHRINGER INGELHEIM PHARMA,
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Signed informed consent in accordance with GCP and local regulatory requirements prior to participation in the study. • Men or women infected by HIV-1> 18 years of age with positive serology (ELISA) confirmed by Western blot • No previous antiretroviral treatment. • Men with CD4 + counts> 50 - 50- 70 (see Appendix 10.4) • An HIV-1 viral load of> 1000 copies / ml • Predisposition to initiate a chemoprophylaxis guided by CD4 lymphocyte count to prevent major opportunistic infections as defined in Appendix 10.2 • Predisposition to abstain from ingesting substances that may alter the levels of the study drug in plasma by interacting with the cytochrome P450 system (listed in Appendix 10.3) during the study. • Only for the centers participating in the PK substudy: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. The refusal to participate in the PK substudy is not an exclusion criterion for participation in the study. Only those study centers with previous experience and equipped for handling PK samples are eligible to participate in the substudy.
Exclusion criteria
Exclusion criteria: • Current abuse of drugs or chronic alcoholism at the discretion of the researcher. • Active hepatitis B or C, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive. Patients who are positive for HBV DNA, negative for HBsAg and positive for anti-HBs antibody of hepatitis will be allowed in the trial. • Women patients with reproductive potential who: have a positive result in the serum pregnancy test at the time of selection, are breastfeeding, plan to become pregnant, do not want to use a barrier method of contraception, do not want to use contraceptive methods except for those oral contraceptives containing ethinyl estradiol. • Laboratory parameters> DAIDS Grade 2 • ALT / AST> DAIDS Grade I • Hypersensitivity to any of the ingredients of the test products. • Prior use of Viraraune® (nevirapine) or any other antiretroviral agent (does not include the use of the single dose of NVP administered with or without an NRTI for the prevention of mother-to-child transmission at least 6 months prior to enrollment) • Resistance to NNRTIs or any of the components of Truvada® (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on the HIV-1 genotypic resistance test report obtained at the time of selection. • Patients who are receiving other concomitant treatments that are not allowed, as described in the prescription information • Use of investigational drugs (any experimental agent other than the study regimen) within 30 days before entry into the study or during the study. • Use of immunomodulatory drugs within 30 days before entering the study or during the study (eg, interferon, cyclosporine, hydroxyurea, interleukin 2) • Patients who are diagnosed with malignancy and who are receiving systemic chemotherapy or are anticipated to receive any therapy during their participation in this trial. • Patients who according to the opinion of the researcher are not candidates for inclusion in the study. • Patient with Progressive Multifocal Leukoencephalopathy (PML) Visceral Kaposi´s Sarcoma (KS) and / or any lymphoma • Any AIDS marker disease that is not resolved, symptomatic or not stable under treatment for at least 12 weeks at the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A virological response is defined by two consecutive measurements of CV <50 copies / ml separated by at least two weeks. A sustained virological response does not present virological rebound or change in ARV therapy during Week 48. Measure:Virological response sustained during Week 48. Timepoints:Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time period between the beginning of the introductory period and the last VL <50 copies / mL in a patient who initially had a virological response prior to Week 48 but subsequently demonstrated virological rebound prior to the time the last enrolled patient had been in treatment for 48 weeks. Measure:Time to loss of virological response Timepoints:Week 48 ; Outcome name:Defined by VL <400 copies / mL prior to Week 48 and without subsequent virological rebounds or change of ARV therapy prior to week 48. Measure:Virological response for Week 48 Timepoints:Week 48 ; Outcome name:Defined as the period of time between the start of the introductory period and the first viral load <50 copies / mL prior to the moment in which the last enrolled patient has been in treatment for 48 weeks. Measure:Time for the virological response Timepoints:48 weeks ; Outcome name:Measurement of time to a new AIDS or progression event related to AIDS or death. Measure:Time to a new AIDS or progression event related to AIDS or death. Timepoints:During the study ; Outcome name:Measurement of CD4 levels during the study Measure:Change from the starting point in VL and CD4 + lymphocyte count at each visit. Timepoints:During the study | — |
Countries
Argentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactFANNY GIOVANA ROSAS
Investigaciones Medicas en Salud - INMENSA
Outcome results
None listed