TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients

NCT00412646 | Completed Phase 2

• 1 other identifier: CR006754
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomized (patients are assigned different treatments based on chance), placebo-controlled, dose-escalating trial is to evaluate the safety, tolerability and efficacy of different doses of TMC125 twice daily ( b.i.d.) when added to an individually optimized antiretroviral therapy (ART) for 48 weeks. Dose-escalation will be performed in two stages. In the first stage approximately one hundred and eighty HIV-1 positive, three-class ART experienced patients will be randomized to placebo, 400 or 800 mg of TMC125 b.i.d. In the second stage, approximately seventy patients will be randomized to placebo, 800 or 1200 mg TMC125 b.i.d. Stage 2 will be opened for enrollment after review of the available safety and efficacy data for a specified number of patients and concurrence by the Data Safety and Monitoring Board (DSMB). After all patients are treated for a period of 12 weeks, unblinding for the sponsor will occur. The trial will continue in a single-blind fashion (sponsor unblinded, but investigator and patient blinded) for up to 48 weeks. Upon completion of the initial 48 weeks of treatment, patients deriving clinical benefit, in the opinion of the investigator, will have the option to prolong the same treatment, in a single-blind setting up to a maximum of 144 weeks.

Conditions

Anti-Retroviral Agents; HIV-1

Keywords

HIV; AIDS; Dose finding study; TMC125-C203; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of different doses of TMC125 b.i.d. (taken twice daily) when added to an individually optimized antiretroviral regimen for 48 weeks.

Secondary Outcomes (1)

• To evaluate the change in viral load; the proportion of patients with a certain plasma HIV-1 RNA level; the protocol defined virologic endpoints; the degree and duration of immunologic change and the number of patients attaining a virologic response

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:

• Plasma viral load at screening visit is above 1,000 HIV-1 RNA copies/ml
• Prior use of NRTI, NNRTI and PI, each for at least 3 months
• Currently receiving a stable (for 8 weeks) ART consisting of at least 3 antiretroviral drugs or currently on a treatment interruption for at least 8 weeks
• Further treatment options as defined by sensitivity to at least 2 antiretroviral drugs based on VirtualPhenotype™

You may not qualify if:

• Active AIDS defining illnesses
• Patients with a history of severe allergy, hypersensitivity or dermatological manifestation that led to discontinuation while receiving any NNRTI or abacavir
• Pregnant or breast-feeding female
• Female of childbearing potential without the use of effective birth control methods
• Any toxicity above grade 2, except for lipids and glucose, according to the ACTG grading severity

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Publications (1)

• Montaner J, Yeni P, Clumeck NN, Fatkenheuer G, Gatell J, Hay P, Seminari E, Peeters MP, Scholler-Gyure M, Simonts M, Woodfall B; TMC125-C203 Study Group. Safety, tolerability, and preliminary efficacy of 48 weeks of etravirine therapy in a phase IIb dose-ranging study involving treatment-experienced patients with HIV-1 infection. Clin Infect Dis. 2008 Oct 1;47(7):969-78. doi: 10.1086/591705.

  PMID: 18764771 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

etravirine

Condition Hierarchy (Ancestors)

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

Study Officials

• Tibotec Pharmaceuticals Limited Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 18, 2006
• Study Start: June 1, 2002
• Study Completion: November 1, 2006
• Last Updated: April 28, 2010

Record last verified: 2010-04