Clinical Trials Resource Center

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.

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