HIV infection
Conditions
Interventions
Trade Name: Viramune ®
Product Name: Viramune ®
Pharmaceutical Form: Pastille
INN or Proposed INN: nevirapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
Esteban Ribera Pascuet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years old 2. Chronic HIV-1 infection confirmed with Western Blot. 3. Patients treated with an efavirenz containing HAART regimen for a minimum of 15 days prior to visit-1. 4. Patients presenting any neuropsychiatric adverse reactions to efavirenz (check Annex D list) and requiring its withdrawal. 5. Ability of the patient to follow the treatment during the planned period. 6. Acceptance and signing of the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hepatic function laboratory values (AST, ALT, GGT) > 3 times the upper normal limit. 2. Serum creatinine >1.5 mg/dl. 3. CD4+ T-lymphocyte values > 400 cells/ml for males or >250 cells/ml for females unless the benefits overcome the risks (technical data file warning) and always under the investigator´s judgement. 4. HIV plasma viral load > 50 copies/ml, in those patients with more than 3 months of treatment with efavirenz. 5. Suspected or confirmed efavirenz and/or nevirapine resistance (e.g. previous virologic failure in a treatment regimen containing one NN-RTI) . 6. Patients currently taking any medicines that could interfere with the absorption, distribution or metabolism of nevirapine (check Annex E). 7. Presence of infections and/or opportunistic neoplasias during the 3 months prior to the entry in the clinical trial. 8. Any condition or medical conditions that in the investigator´s opinion, could interfere with the ability of the subject to take part or comply with the requirements of this protocol. 9. Pregnancy. 10. Suspected primary infection less than 6 months long.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the nevirapine trough plasma levels after 7 days of initial full dose nevirapine treatment or following the dose escalation treatment in patients taking efavirenz and switching to nevirapine due to neuropsychiatric adverse reactions.;Secondary Objective: -To measure the short term efficacy of the nevirapine treatment following efavirenz withdrawal. -To compare the safety of the initial full dose nevirapine treatment with the dose escalation nevirapine treatment. -To determine efavirenz plasma levels prior to its withdrawal and on days 3, 7 and 14 after it. -To know treatment compliance after switching from efavirenz to nevirapine. -To know the evolution of the neuropsychiatric adverse reactions to efavirenz that caused its withdrawal. ;Primary end point(s): The proportion of patients with nevirapine trough plasma concentration within therapeutic levels after 7 days of treatment. | — |
Countries
Spain
Outcome results
None listed