HIV Infection Clinical Trial
Official title:
A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.
Status | Completed |
Enrollment | 604 |
Est. completion date | October 2011 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient has documented HIV-1 infection - Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks - Plasma HIV-1 RNA >1000 copies/mL - General medical condition does not interfere with the assessments and the completion of the trial Exclusion Criteria: - Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval) - tenofovir, emtricitabine, atazanavir, fosamprenavir - Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114 - Life expectancy of less than 6 months - Pregnant or breast-feeding - Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period - Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels - Participation in other investigational trials without prior approval of the sponsor |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tibotec Pharmaceuticals, Ireland |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Guatemala, Hungary, Malaysia, Mexico, Netherlands, Panama, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Switzerland, Thailand, United Kingdom,
Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Béthune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population) | 48 weeks | No | |
Secondary | Number of Participants with Adverse Events | 96 weeks | Yes | |
Secondary | Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population) | 96 Weeks | No |
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