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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Phase IIb Randomized, Partially Blinded, Dose-finding Trial of TMC278 in Antiretroviral Naive HIV-1 Infected Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Efavirenz Rilpivirine

U.S. FDA Resources

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

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:	372
Study Start Date:	May 2005
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

Show 43 Study Locations

Sponsors and Collaborators

Tibotec Pharmaceuticals, Ireland

Investigators

Study Director:

Tibotec Pharmaceuticals Clinical Trial

Tibotec Pharmaceutical Limited

More Information

No publications provided by Tibotec Pharmaceuticals, Ireland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010 Jan 2;24(1):55-65.

Responsible Party:	Compound Development Team Leader TMC278, Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier:	NCT00110305 History of Changes
Obsolete Identifiers:	NCT00980837
Other Study ID Numbers:	CR006760, TMC278-C204
Study First Received:	May 5, 2005
Last Updated:	August 7, 2012
Health Authority:	United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Tibotec Pharmaceuticals, Ireland:

HIV infection
TMC278
HIV-1
TMC278-C204

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

Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013