Status:
TERMINATED
NNRTI/PI Toxicity Switch to Darunavir Study
Lead Sponsor:
St Stephens Aids Trust
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to examine the effects of switching from antiretroviral combinations that includes efavirenz (Sustiva®), lopinavir/ritonavir (Kaletra®) or atazanavir/ritonavir (Reyataz®/No...
Detailed Description
The advent of highly active antiretroviral therapy (HAART) has revolutionised the treatment of HIV disease, with both patients and physicians enjoying the marked reductions in HIV related morbidity an...
Eligibility Criteria
Inclusion
- HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
- Subject is currently on an antiretroviral regimen comprising of at least three licensed antiretroviral agents including efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir
- Subject is virologically suppressed with a viral load \< 50 copies/ml
- Subject has a CD4+ count above 50 cells/ml
- If subject is a female of childbearing potential, she must agree to use a double barrier method of contraception
- No previous exposure to darunavir
Exclusion
- Pregnant or lactating women
- Any female of childbearing potential not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs)
- Heterosexually active male subject not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational ARVs)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00765154
Start Date
October 1 2008
End Date
July 1 2010
Last Update
November 1 2010
Active Locations (1)
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1
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9TH