Clinical Trials

TMC278-TiDP6-C209

Sponsor:
Tibotec

Study Title:
CLOSED TO ACCRUAL. A Clinical Trial in Treatment Naïve HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

Summary:
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278, a new NNRTI, given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs.

The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

Phase:
Phase 3

Study Design:
Over the past decade, anti-human immunodeficiency virus (HIV) drugs have been introduced sequentially for use in the clinic. Currently, patients are routinely being treated with 3 or 4 drug combinations including nucleoside/tide analogue reverse transcriptase inhibitors (NRTIs/NtRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and/or fusion inhibitors. New potent antiretroviral (ARV) compounds that are active in persons whose HIV-1 virus is resistant to available drugs are urgently needed.

This is a randomized, double-blind, double-dummy, active-controlled trial to compare the effectiveness, safety, and ability to tolerate TMC278 versus efavirenz (EFV). The study will last for 104 weeks which includes a screening period of 4 weeks, a 96-week treatment period, followed by a 4 week follow-up period. Patients will be randomly assigned to TMC278 or to efavirenz, either of these treatments will be in combination with 2 NRTIs: emtricitabine (FTC) + tenofovir (TDF). TDF/FTC will be administered as a fixed dose combination if available.

The hypothesis is that the investigational drug TMC278 will be at least non-inferior to EFV in terms of antiviral effectiveness (< 50 HIV-1 RNA copies/mL) and possibly a better tolerated option for ART naïve patients. Health status will be monitored by targeted history and physical examination, and laboratory testing on blood and urine samples, all of which are provided at no charge to the patient. In addition, there will be a DEXA substudy to evaluate changes in body fat distribution (limb fat, trunk fat, total body fat)  and bone mineral density comparing the two treatment arms.  A PK substudy will be performed to evaluate population pharmacokinetics and PK/PD relationships for efficacy and safety of TMC278 in combination with TDF and FTC.

Experimental Group: One tablet of TMC278 25 mg once daily plus one tablet of efavirenz (EFV) placebo once daily plus tenofovir/emtricitabine.

Control Group: One tablet of TMC278 placebo once daily plus EFV 600 mg once daily plus tenofovir/emtricitabine.

Eligibility Criteria:

 Inclusion Criteria:

• Patient with documented HIV-1 infection
• Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
• Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
• Patient's virus is sensitive to TDF and FTC
• Patient agrees not to start ART (antiretroviral treatment) before the baseline visit

Exclusion Criteria:

• Previous use of ANY ARV drug for ANY length of time
• Any documented evidence of NNRTI resistance associated mutations in patient's HIV
• Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if not progressive
• Pneumocystis carnii pneumonia (PCP) that is considered not cured
• Active TB
• Allergy or hypersensitivity to study or background ARTs
• Specific grade 3 or 4 toxicity
• Kidney impairment: calculated creatinine clearance <50 ml/min

Drugs/Treatment Provided:

Arms:

001: Experimental:    Drug: TMC278 25 mg tablet once daily for 96 weeks

002: Active Comparator:   Drug: efavirenz 600mg once daily for 96 weeks

Compensation:
$70 for entry visit and $30 for all other visits. 

Study Duration: 104 weeks

Principal Investigator: Donna Mildvan, M.D.

Study Location: Beth Israel Medical Center

Infectious Diseases/AIDS Clinical Trials Unit

350 East 17th Street, 3rd floor

New York, NY, 10003

Contact Information: Phone: 212-420-4519 or 800-483-7339 Email

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TMC278-TiDP6-C209
CLOSED TO ACCRUAL. A Clinical Trial in Treatment Naïve HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

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