Status:
COMPLETED
VENICE Study Nevirapine Full Dose/Dose Escalation
Lead Sponsor:
Clinical Trial Agency of HIV Study Group
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 nevir...
Detailed Description
The prognosis for HIV infection changed radically after 1996 thanks to the arrival of protease inhibitors (PI), which, when combined with 2 nucleoside analogue reverse transcriptase inhibitors (NRTI) ...
Eligibility Criteria
Inclusion
- 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- Patients who present a neuropsychiatric adverse reaction to efavirenz (see list in Appendix D) and require it to be withdrawn.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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00704249
Start Date
July 1 2006
End Date
February 1 2009
Last Update
February 11 2009
Active Locations (15)
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1
Hospital General Alicante
Alicante, Alicante, Spain
2
Hospital General de Elche
Elche, Alicante, Spain
3
Hospital Germanas Trias i Pujol
Badalona, Barcelona, Spain
4
Hospital del Mar
Barcelona, Barcelona, Spain, 08003