A Phase 2 interventional study of TMC114 in HIV Infection, sponsored by Tibotec Pharmaceuticals, Ireland. Completed at 68 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-20.
Sponsored by Tibotec Pharmaceuticals, Ireland · Phase 2, Interventional, and Treatment
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 555 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Tibotec Pharmaceuticals, Ireland is the lead sponsor of 75 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Drug: TMC114
600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline.
Time frame: 24 weeks
Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points
Time frame: 144 weeks
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Tibotec Pharmaceuticals, Ireland