TMC278-C204: TMC278 in Treatment Naive HIV-1 Infected Subjects - Full Text View

Sponsored by:	Tibotec Pharmaceutical Limited
Information provided by:	Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier:	NCT00110305

Purpose

This is a study of a new, experimental Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC278. The study will help determine a safe and effective dose of this new drug.

Condition	Intervention	Phase
HIV Infection	Drug: TMC278 Drug: Efavirenz	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Rilpivirine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIb Randomized, Partially Blinded, Dose-Finding Trial of TMC278 in Antiretroviral Naive HIV-1 Infected Subjects

Further study details as provided by Tibotec Pharmaceutical Limited:

Primary Outcome Measures:

To evaluate the dose-response relationship of antiviral activity after 48 weeks treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate antiviral activity of 96 weeks; Safety and tolerability of TMC278; Compare safety and efficacy with the control group; Evaluate immunologic and viral genotype changes; Evaluate drug susceptibility and pharmacokinetics [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	368
Study Start Date:	May 2005
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
001: Experimental	Drug: TMC278 25mg once daily for 96 weeks
002: Experimental	Drug: TMC278 75mg once daily for 96 weeks
003: Experimental	Drug: TMC278 150mg once daily for 96 weeks
004: Experimental	Drug: TMC278 75mg once daily from 96 weeks to 144 weeks
005: Active Comparator	Drug: Efavirenz 600mg Efavirenz once daily for 144 weeks

Detailed Description:

This is a study of a new, experimental Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC 278. The study will help determine a safe and effective dose of this new drug. People included in this study will be treatment naive, which means they have not previously received treatment with antiretroviral therapy, or have been treated for a maximum of 2 weeks with licensed protease inhibitors (PIs) or nucleoside reverse transcriptase inhibitor (NRTIs). The study will last for 152 weeks. This includes a 4-week screening period, a 144-week treatment period and a 4-week follow-up period. Three different doses of TMC 278 will be compared to efavirenz. HIV infected subjects will be randomly assigned (like tossing a coin) to TMC278 or to efavirenz in combination with two other anti-HIV drugs (fixed backbone) selected by the participant's doctor.

Three different doses of TMC278 in the partially blinded part of the trial. In open-label part only one dose (75mg).;

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented HIV-1 infection
Plasma viral load at screening visit above 5000 HIV-1 RNA copies/ml
Never been treated with an antiretroviral (ARV) drug or therapeutic HIV vaccine, or have received < 2 week's treatment with an NRTI and/or PI prior to screening
Agree not to start ARV treatment before the baseline visit

Exclusion Criteria:

Subject has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness except stable, cutaneous Kaposi's Sarcoma or Wasting Syndrome due to HIV infection
Clinically significant disease (e.g., pancreatitis, cardiac dysfunction)
Subject has known or suspected acute (primary) HIV-1 infection
Any prior use of NNRTIs for > 2 weeks
Acute hepatitis A, B, or C infection
Receipt of any investigational drug within 90 days prior to trial initiation and first dosing of study medication
Pregnant or breastfeeding female
Males or Females not willing to take the recommended precautions to avoid pregnancy during the trial
Any grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading severity list except for isolated grade 3 elevations of gamma glutamyl transferase (GGT)
Tuberculosis
History of or currently active alcohol or drug use which in the opinion of the investigator will likely compromise subjects' safety and/or compliance with trial procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110305

Sponsors and Collaborators

Tibotec Pharmaceutical Limited

Investigators

Study Director:

Tibotec Clinical Trial

Tibotec Pharmaceutical Limited

More Information

Responsible Party:	Tibotec Pharmaceutical Limited ( Compound Development Team Leader TMC278 )
Study ID Numbers:	CR006760, TMC278-C204
Study First Received:	May 5, 2005
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00110305
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tibotec Pharmaceutical Limited:

HIV-1
TMC278-C204
TMC278
HIV infection

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Signs and Symptoms
Sexually Transmitted Diseases, Viral
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009