Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302341
Status:
TERMINATED
Last Update Posted:
2013-03-07
First Post:
2006-03-10
Brief Title:
DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia PCP
Sponsor:
Immtech Pharmaceuticals Inc
Organization:
Immtech Pharmaceuticals Inc
Study Overview
Official Title:
International Randomized Controlled Phase 3 Trial of DB289 Versus Trimethoprim-sulfamethoxazole for the Treatment of Acute Pneumocystis Jiroveci Pneumonia PCP in Patients With HIVAIDS
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA Clinical Hold as of 122107 due to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate DB289versus trimethoprim-sulfamethoxazole TMP-SMXfor the treatment of mild to moderately severe Pneumocystis pneumonia PCP
Detailed Description:
The gold standard treatment for PCP is trimethoprim-sulfamethoxazole TMP-SMX This drug is highly effective however a significant number of patients are unable to complete a course of therapy due to adverse events some of which can be life-threatening In addition mutations that confer resistance to sulfa-based drugs in other microorganisms are increasingly being reported in P jiroveci A potential role of these mutations in conferring clinical resistance to PCP and in breakthroughs to prophylaxis regimens based on sulfa drugs is being actively studied Second and third line agents or combinations for PCP treatment are also limited in efficacy andor by adverse events
A new agent such as pafuramidine maleate DB289 which has well documented activity against P carinii in animal models documented efficacy in a preliminary study trial in HIV-infected patients with PCP that were intolerant or resistant to TMP-SMX was well tolerated in this trial and demonstrated a low toxicity profile in Phase 1 studies would meet a significant medical need Furthermore pafuramidine maleate is active against other pathogens responsible for significant morbidity and mortality in patients with AIDS in the developing world like different strains of Plasmodium malaria and Cryptosporidium parvum The decrease in the rate of PCP in countries where patients with AIDS have access to HAART will present a significant challenge to the completion of this development program The last published trial of PCP treatment was conducted by the ACTG in 24 US sites between May 1991 and june 1993 That study needed to decrease the planned sample size to 195 due to low enrollment This represents an important challenge for our program
A new agent such as pafuramidine maleate DB289 which has well documented activity against P carinii in animal models documented efficacy in a preliminary study trial in HIV-infected patients with PCP that were intolerant or resistant to TMP-SMX was well tolerated in this trial and demonstrated a low toxicity profile in Phase 1 studies would meet a significant medical need Furthermore pafuramidine maleate is active against other pathogens responsible for significant morbidity and mortality in patients with AIDS in the developing world like different strains of Plasmodium malaria and Cryptosporidium parvum The decrease in the rate of PCP in countries where patients with AIDS have access to HAART will present a significant challenge to the completion of this development program The last published trial of PCP treatment was conducted by the ACTG in 24 US sites between May 1991 and june 1993 That study needed to decrease the planned sample size to 195 due to low enrollment This represents an important challenge for our program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None