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spread the word: new clinical trials for tmc 114 and tmc 125
May 12, 2004

Hi Nelson,

Wanted to let you and others know about this. Stay well and keep fighting tiger!

Dave

Recruitment Is Open for Trials of Experimental Protease Inhibitor TMC114 and Experimental NNRTI TMC 125

Phase 2 Study of PI TMC 114 and low dose ritonavir

The purpose of this study is to determine the effectiveness, safety, and tolerability of the investigational protease inhibitor (PI) TMC 114 given with low dose ritonavir.

Subjects who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate.

Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 48 weeks.

Eligibility

Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: Both

Major Inclusion Criteria

Male or female, age 18 years or older.

Documented HIV-1 infection.

Stable PI regimen for at least 8 weeks prior to screening.

Plasma viral load at screening above 1000 HIV-1 RNA copies/ml.

Prior use of more than 1 NRTI for at least 3 months.

Prior use of one or more NNRTIs as part of a failing regimen.

At least 1 primary PI mutation as defined by the IAS guidelines.

Treatment with at least two different PIs for a total of at least 3 months.

Suject has given informed consent.

Major Exclusion Criteria

Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection.

Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures.

NNRTI as part of therapy at screening.

Patients on a treatment interruption at screening.

Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening.

Hepatitis A, B, or C.

Expected Total Enrollment: 300

Complete Trial Description

Roll-over Trial Only for HIV-infected Subjects in Control Groups of Selected TMC 114 Trials Who Fail Treatment

The purpose of the study is to allow subjects who failed trial treatment in the control group of the TMC114-C202 or TMC114-C213 trials to begin therapy with an investigational protease inhibitor (PI) called TMC114 given with a low dose of ritonavir (RTV).

The trial will also evaluate the safety and tolerability of TMC114/RTV. Subjects who participated in the control arm of the TMC114-C202 or TMC114-C213 trial and who meet the specifically defined criteria for virological failure are eligible for screening for TMC114-C215.

Furthermore, subjects must have participated in the treatment phase of one of the original trials for at least 12 weeks before becoming eligible for TMC114-C215 screening.

A possible 120 subjects many be eligible for the study (the total number of subjects expected in TMC114-C202 and TMC114-C213 control arms) and the study duration is 48 weeks with a possibility of extension. The study is being conducted in the same countries and sites as the TMC114-C202 and TMC114-C213 trials.

Major Inclusion Criteria:

Previous participation in the control group of the TMC114-C202 or TMC114-C213 trials

Significant virologic failure during participation in a control group of the above trials

Subject participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening

Subject agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs) with or without T-20 from baseline onwards

Subject has given informed consent

Major Exclusion Criteria:

Current or past history of active alcohol and/or drug use which in the investigators opinion would compromise the subjects safety or compliance to the study protocol procedure

Use of disallowed concomitant therapy

Subject with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels

Any active or unstable medical condition that, in the investigators opinion, would compromise the subjects safety

Subject with laboratory abnormalities at screening as defined by ACTG grading scheme

Subject withdrawing consent from TMC114-C202 or TMC114-C213

Expected Total Enrollment: 120

Complete Trial Description

TMC 125 in HIV-infected Subjects

Purpose

The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.

TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given a dosage of TMC125, 400 mg twice daily. Another will be given 800 mg twice daily. The third group, a control arm, will not receive TMC125.

The safety, tolerability and pharmacokinetics (determinations of the concentration of drug in your blood and its evolution over time) of TMC125 will also be evaluated in this study. Patients who have known resistance to NNRTIs and 3 or more protease inhibitor (PI) mutations may be eligible to participate.

One-hundred-fifty (150) patients will be enrolled into this study.

Eligibility

Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: Both

Inclusion Criteria:

HIV-1 plasma viral load at screening >1000 copies/ml

Documented genotypic evidence of resistance to currently available NNRTIs

Previous NRTI experience for at least 3 months

3 primary PI mutations at screening

Exclusion Criteria:

Chronic HBV and/or HCV with elevated liver function tests > 3x upper normal limits

Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)

Previous permanent discontinuation of any NNRTI due to cutaneous events

Expected Total Enrollment: 150

Complete Trial Description

05/03/04

Source

Clinical Trials.gov

Response from Mr. Vergel

Thanks. Keep in mind that you cannot be Hep A, B or C positive. Nelson



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