HIV Clinical Trial
Official title:
Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.
The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).
Status | Completed |
Enrollment | 692 |
Est. completion date | May 2012 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with documented HIV-1 infection - Screening plasma HIV-1 RNA >= 5000 copies/mL - Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines - Patients who can comply with the protocol requirements - General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. Exclusion Criteria: - Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection - Life expectancy of less than 6 months - Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity - Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period - -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) < 70 mL/min |
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, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Guatemala, Malaysia, Mexico, Panama, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom,
Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, Workman C, Dierynck I, Sekar V, Abeele CV, Lavreys L. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009 A — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48 | 48 weeks | No | |
Secondary | Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment | 192 weeks | No |
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