Clinical Trials Resource Center

New Medical Therapies™

Strep Throat

August 1, 2005

Advancis issued negative results of their phase III trial of amoxicillin PULSYS, for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections (strep throat). Trial data did not meet their primary efficacy endpoint, failing to achieve statistical non-inferiority to penicillin in bacterial eradication at post-therapy test-of-cure visit (65.3% vs. 68.0%, respectively). The drug also failed to demonstrate secondary non-inferiority in clinical cure at the test-of-cure visit and in bacterial eradication at late post-therapy follow-up. This controlled study enrolled pediatric patients, who received one of two doses of oral amoxicillin PULSYS (475 mg or 775mg once daily) or an oral suspension of penicillin (10 mg/kg 4 times daily) for 10 days.

Pfizer issued positive results of a set of phase I/II trials of maraviroc, for the treatment of HIV infections, at the 3rd International AIDS Society Conference on Pathogenesis and Treatment. Safety results from 6 studies indicated that the drugs toxicity and tolerability was comparable to placebo at multiple dose levels. A pair of monotherapy studies indicated that the drug reduced HIV viral load by 1.6-1.84 log across multiple dose regimens (200 mg to 600 mg total daily dose) after 10 days; the degree of reduction was not dose-dependent. Absorption data indicated that the drug could be administered with or without food. The 6 safety studies enrolled 259 healthy volunteers and HIV patients, who received short term regimens of up to 300 mg maraviroc twice daily. The dose-ranging monotherapy trials treated 63 patients for 10 days.

June 20, 2005

Advancis and Par have issued negative results of a phase III trial of their investigational antibiotic Amoxicillin PULSYS, for the treatment of Group A streptococcal pharyngitis/tonsillitis. Trial data failed to meet their primary non-inferiority endpoint, with 76.6% of patients achieving bacterial eradication at the end of treatment, compared to 88.5% of subjects receiving penicillin. Secondary non-inferiority endpoints were also missed, including clinical cure at the test-of-cure visit and bacterial eradication at the late post-therapy visit. This open-label study enrolled 353 patients, who received either 775 mg Amoxycillin PULSYS once-daily for seven days or 250 mg penicillin VK four times daily for ten day. The companies anticipate that these results will delay NDA filing by at least 1 year.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.