# 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.

> **NCT00255099** · PHASE3 · COMPLETED · sponsor: **Tibotec Pharmaceuticals, Ireland** · enrollment: 593 (actual)

## Conditions studied

- HIV

## Interventions

- **DRUG:** TMC125
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00255099
- **Lead sponsor:** Tibotec Pharmaceuticals, Ireland
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2005-12
- **Primary completion:** 2007-01
- **Final completion:** 2008-07
- **Target enrollment:** 593 (ACTUAL)
- **Last updated:** 2011-06-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00255099

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00255099, "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.". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT00255099. Licensed CC0.

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