TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial

NCT00111280 | Completed Phase 2

• 1 other identifier: CR006742
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase II, open-label, roll-over trial to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated.

Conditions

HIV Infection

Keywords

HIV infection; TMC125; Nucleoside reverse transcriptase inhibitors (NRTIs); roll-over trial; antiretrovirals (ARVs)

Outcome Measures

Primary Outcomes (1)

• The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC125.

Secondary Outcomes (1)

• The secondary objectives are to evaluate the antiviral activity and immunological effect of TMC125 as part of an antiretroviral (ARV) regimen over time, and to evaluate genotypic and phenotypic changes over time.

Interventions

TMC125 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed the Informed Consent Form (ICF) voluntarily
• Male or female subject, aged 18 years and above
• Subject having previously been randomized to an active control arm of a sponsor selected TMC125 trial and has completed the entire treatment period or has met the definition of virological failure, as defined in the original protocol, before TMC125 C211 screening or subjects who were randomized in a fully blinded TMC125 trial, being unblinded after treatment for at least 48 weeks and identified as having received placebo
• Subject agrees to take TMC125 in combination with the investigator-selected combination therapy consisting of at least 2 drugs (NRTIs and/or allowed PI and/or T-20
• low-dose ritonavir \[= 400 mg daily dose\] is not counted as a separate ARV)
• Subject can comply with the protocol requirements
• Subject's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial

You may not qualify if:

• History of or currently active alcohol or substance use which in the investigator's opinion would likely compromise the subject's safety or compliance with the study procedures
• Any active clinically significant disease (e.g., tuberculosis, cardiac dysfunction) or findings during physical examination that, in the investigator's opinion, would compromise the subject's safety
• Renal impairment as defined by serum creatinine \> 2 x upper limit of normal (ULN)
• Any grade 3 or grade 4 toxicity according to the AIDS Clinical Trial Group (ACTG) grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevations
• or asymptomatic and isolated grade 3 or 4 elevations in gamma-glutamyl transferase \[GGT\] with all other liver enzymes and bilirubin within normal ranges, or isolated grade 3 elevation in amylase with no increase in lipase and no history of pancreatitis)
• Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio \> 1.3 or albumin \< 30 g/l or direct bilirubin \> 2.5 x ULN).

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Links

• Clinical Study Report Synopsis of TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial.

MeSH Terms

Conditions

HIV Infections

Interventions

etravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2005
• First Posted: May 19, 2005
• Study Start: September 1, 2004
• Study Completion: March 1, 2007
• Last Updated: May 19, 2011

Record last verified: 2010-04