HIV Infections Clinical Trial
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 HIV/AIDS
The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate (DB289)versus trimethoprim-sulfamethoxazole (TMP-SMX)for the treatment of mild to moderately severe Pneumocystis pneumonia (PCP).
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 and/or 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 U.S. 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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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