TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
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ClinicalTrials.gov Identifier: NCT00255099 |
Recruitment Status
:
Completed
First Posted
: November 17, 2005
Last Update Posted
: June 15, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: TMC125 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 593 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options. |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 001
TMC125 2 x 100 mg tablets b.i.d. / 96 weeks
|
Drug: TMC125
2 x 100 mg tablets b.i.d. / 96 weeks
|
Placebo Comparator: 002
Placebo 2 tablets b.i.d. / 96 weeks
|
Drug: Placebo
2 tablets b.i.d. / 96 weeks
|
- Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has 3 or more primary protease inhibitor mutations
- documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation
- on a stable antiretroviral therapy for at least 8 weeks
- plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.
Exclusion Criteria:
- Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
- Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
- Use of disallowed concurrent therapy
- Any active clinically significant disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255099
Study Director: | Tibotec Pharmaceuticals Clinical Trial | Tibotec Pharmaceutical Limited |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Compound Development Team Leader TMC125, Tibotec Pharmaceutical Limited |
ClinicalTrials.gov Identifier: | NCT00255099 History of Changes |
Other Study ID Numbers: |
CR006307 TMC125-C216 |
First Posted: | November 17, 2005 Key Record Dates |
Last Update Posted: | June 15, 2011 |
Last Verified: | June 2011 |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV HIV-1 TMC125 |
Additional relevant MeSH terms:
Darunavir Etravirine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |