An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: TMC114 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects. |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 555 |
| Study Start Date: | November 2003 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous participation in the TMC114-C202 or TMC114-C213 trials
- Significant virologic failure during participation in the above trials
- Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
- Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
- Patient has given informed consent
Exclusion Criteria:
- Use of disallowed concomitant therapy
- Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
- Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
- Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
- Patient withdrawing consent from TMC114-C202 or TMC114-C213
Contacts and Locations More Information
Publications:
| Responsible Party: | Compound Development Team Leader TMC114, Tibotec Pharmaceutical Limited |
| ClinicalTrials.gov Identifier: | NCT00081588 History of Changes |
| Obsolete Identifiers: | NCT00980226 |
| Other Study ID Numbers: | CR006724, TMC114-C215 |
| Study First Received: | April 15, 2004 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
|
TMC114-C215 Ritonavir HIV infections TMC114-C202 TMC114-C213 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013