Status:
COMPLETED
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
Lead Sponsor:
Tibotec, Inc
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase...
Detailed Description
This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIIb clinical trial to evaluate the effectiveness, safety and tolerability of the combination of PREZIST...
Eligibility Criteria
Inclusion
- Documented HIV-1 positive
- History of drug resistance or antiretroviral failure while receiving each of three drug classes: Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and (protease inhibitors) PIs
- On a PI containing regimen with enfuvirtide with HIV viral load (VL) \< 400 copies/mL for 6 months or longer
- Continuously using the same PI regimen for 4 months prior to Screening
- Decline to continue enfuvirtide or their physician recommends discontinuation due to injection site reactions that persist despite optimal technique and training with available methods of administration or loss of sites for injection due to tissue nodules and hardening.
Exclusion
- No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125
- No prior or current therapy with PREZISTA (darunavir) or TMC125
- No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). Patients with \> 3 darunavir resistance-associated mutations with available darunavir phenotypes, may be enrolled if the resistance phenotype demonstrates: Fold Change (FC) \<10 to darunavir by PhenoSense GT (Monogram Biosciences) or FC \<10 to darunavir by Antivirogram (Virco, BVBA) or FC \<3.4 to darunavir by vircoTYPE (Virco BVBA)
- AST or ALT \>5 times ULN
- Calculated CrCl \< 30 ml/min.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00460746
Start Date
May 1 2007
End Date
October 1 2008
Last Update
July 31 2013
Active Locations (1)
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1
Los Angeles, California, United States