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	Treatment or Intervention	Phase
HIV Infection	Drug: TMC278	Phase II

Further Study Details: 

Primary Outcomes: To evaluate the dose-response relationship of antiviral activity after 48 weeks treatment
Secondary Outcomes: To evaluate antiviral activity of 96 weeks; To evaluate safety and tolerability of TMC278; To compare safety and efficacy with the control group; To evaluate immunologic changes; To evaluate changes in viral genotype and drug susceptibility; To evaluate the pharmacokinetics of TMC278
Expected Total Enrollment:  320

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 104 weeks. This includes a 4-week screening period, a 96-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 selected by the participant's doctor (fixed backbone).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00110305

California
      AIDS Healthcare Foundation Research Center, Los Angeles,  California,  90015,  United States
District of Columbia
      Whitman Walker Clinic, Washington,  District of Columbia,  20009,  United States
Florida
      Orlando Immunology Center, Orlando,  Florida,  32701,  United States
New York
      University at Stony Brook Health Sciences Centre, Division of Infectious Diseases, Stony Brook,  New York,  11794,  United States
Texas
      Nicholaos C Bellos, MD, PA, Dallas,  Texas,  75246,  United States
Puerto Rico
      Clinical Research Puerto Rico, Inc., San Juan,  Puerto Rico

Study ID Numbers:  TMC278-C204
Record last reviewed:  May 2005
Last Updated:  May 6, 2005
Record first received:  May 5, 2005
ClinicalTrials.gov Identifier:  NCT00110305
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17