VENICE Study Nevirapine Full Dose/Dose Escalation

Inclusion Criteria:

• Age ³ 18 years
• Chronic HIV-1 infection confirmed by Western blotting
• Patients treated with a HAART regimen containing efavirenz for a minimum of 15 days before the baseline visit
• Patients who present a neuropsychiatric adverse reaction to efavirenz (see list in Appendix D) and require it to be withdrawn.
• Ability of the patient to follow treatment during the period established
• Acceptance and signing of the informed consent document

Exclusion Criteria:

• Liver function test (AST, ALT, GGT) results > 3 times the upper limit of normal.
• Elevated creatinine levels (>1.5 mg/dL)
• CD4+ T-cell count > 400 cells/µL in men or > 250 cells/µL in women, unless the benefit outweighs the risk (warning in the summary of product characteristics) and always at the investigator's discretion
• HIV plasma viral load > 50 copies/mL in those patients who have been taking efavirenz for more than 3 months
• Suspected or confirmed resistance to efavirenz and/or nevirapine
• Patients who are currently taking a drug that might interfere in the absorption, distribution, or metabolism of nevirapine
• Presence of opportunistic infections and/or neoplasm during the 3 months before the start of participation in the trial
• Any medical condition(s) that, in the investigator's opinion, might interfere with the patient's ability to participate or fulfill the requirements of the present protocol
• Pregnancy
• Suspected primary infection of less than 6 months' duration