A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 \< 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patient must have the following:
• • Presumptive diagnosis of AIDS as defined by the CDC.
• • Untreated Pneumocystis carinii pneumonia (PCP).
• • Willingness and ability to give informed consent.
• Prior Medication:
• Allowed:
• • Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Judged by the investigator to be in impending respiratory failure.
• • Malabsorption or vomiting that would, in the judgment of investigator, potentially limit the retention and absorption of an oral therapy.
• • Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.
• Concurrent Medication:
• Excluded:
• • Corticosteroid treatment (except replacement therapy or patients in Group B).
• • Ganciclovir.
• • Zidovudine (AZT).
• • Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.).
• Drugs likely to have anti-pneumocystis effect such as:
• • Sulfonamides.
• • Pentamidine.
• • Dapsone.
• • Trimethoprim.
• • Other DHFR inhibitors.
• • Primaquine.
• • Clindamycin.
• • Sulfonylureas.
• Patients with the following are excluded:
• • Judged by the investigator to be in impending respiratory failure.
• • Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP.
• • Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period.
• • Unable to take medication orally or unwilling or unable to take study medication with food.
• • Significant psychosis or emotional disorder such that, in the investigator's opinion, the patient would not be compliant with the study protocol.
• • Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• • Prior history of life-threatening toxicity to SMX/TMP such as severe rash or Stevens-Johnson syndrome.
• Prior Medication:
• Excluded:
• • Prior therapy for this episode of Pneumocystis carinii pneumonia (PCP) or treatment within 4 weeks for a prior episode of PCP.
• • Blood transfusions.

Trial Officials