Overview

VENICE Study Nevirapine Full Dose/Dose Escalation

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
Summary
This study aims to compare the trough plasma concentrations of nevirapine after 7 days of treatment at the full dose from baseline with dose escalation in patients taking efavirenz who switch to nevirapine due to neuropsychiatric adverse reactions.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clinical Trial Agency of HIV Study Group
Treatments:
Nevirapine
Criteria
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Appendix D) and require it to be withdrawn.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