|Phase I/II Trials|
We administered intravenous T-20 (monotherapy) for 14 days to sixteen HIV-infected adults in four dose groups (3, 10, 30 and 100 mg twice daily). There were significant, dose-related declines in plasma HIV RNA in all subjects who received higher dose levels... This study provides proof-of-concept that viral entry can be successfully blocked in vivo. Short-term administration of T-20 seems safe and provides potent inhibition of HIV replication comparable to anti-retroviral regimens approved at present.
welve treatment-experienced or treatment-na´ve children ages three to 12 were evaluated in a Phase I/II study being conducted in collaboration with the Pediatric AIDS Clinical Trials Group (PACTG) of the National Institute of Allergy and Infectious Diseases. The preliminary findings suggest that short-term (up to 12 weeks) subcutaneous dosing with T-20 is well tolerated by children and that in the highest dose group (60 mg/m2), T-20 caused rapid suppression of HIV RNA of approximately 10-fold average reduction from baseline levels in seven days.
|Phase II Trials|
In the Phase II clinical trial, T-20 was given for twenty-eight days to 78 HIV infected adults. T-20 was administered via continuous subcutaneous infusion or subcutaneous injection and was added to a stable antiretroviral regimen or administered as monotherapy. Mild to moderate local skin irritation at the site of infusion or injection was observed in most patients. However, only 3% of patients discontinued T-20 due to side effects during this trial.
In the T20-205 Phase II single arm, open label roll-over trial, 70 patients received T-20 50 mg twice daily (BID) by subcutaneous injection in combination with other anti-HIV drugs. Prior to starting the trial, the patients had failed on average 10 HIV/AIDS medications and entered with high viral load (median 4.8 log10 copies/mL) and low CD4 cell count (median 135 cells/mm3), characteristic of advanced HIV disease. At 48 weeks, 23 patients exhibited reductions in the amount of HIV in their blood that were 10-fold lower than baseline and/or were reduced below the lower limit of the Roche AMPLICOR HIV-1 MONITORTM assay (400 copies/mL). This translates to a response rate of 56% (23/41) of patients completing 48 weeks of treatment or 33% of the entire population who entered the study.
Forty-eight week results of T-20 in combination with oral antiretrovirals suggest that the addition of T-20 to a standard antiretroviral regimen was well tolerated and provided additional decreases in plasma viral load than that provided by the antiretroviral control regimen alone. In the strict intent-to-treat, missing equals failure analysis, 55 percent of patients (28 of 51) in the combined T-20 arms achieved undetectable HIV-RNA levels of less than 400 copies/mL, and 47 percent (24 of 51) reached the lower threshold of HIV-RNA levels of less than 50 copies/mL. In the control group, 37 percent of patients (seven of 19) achieved HIV-RNA levels of less than 50 copies/mL and 400 copies/mL. CD4+ cell count increases were also higher in patients treated with T-20 containing regimens - 132 cells cells/?l compared to 90 cells/?l in the control group.
"After long term treatment (48 weeks), half (23 of 46) of the triple-class experienced patients who used T-20 in combination therapy had their viral loads reduced beneath the limit of detection of the Roche AMPLICOR( viral load assay (<400 copies/mL). This is an impressive result for this growing and difficult to treat population," stated Dr. Joseph Wheat, Professor of Medicine, Indiana University School of Medicine, Division of Infectious Diseases. "We are also delighted to see that virtually all patients in the study (93 percent of 46 patients) completed a full year of treatment, indicating that long term treatment with T-20 administered subcutaneously twice-daily is tolerable and acceptable to these patients."
|Phase III Trials|
In early 2002, Trimeris and Roche jointly report that they had reached "24-Week Results" for the two Phase III trails being conducted for submission to the FDA for marketing approval, and that the companies will "proceed with filing US and EU registration packages." The trials includes included "approximately" 1,000 patients and each last for a total of 48 weeks.
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