INTERNATIONAL, RANDOMIZED, CONTROLLED PHASE 3 STUDY, OF DB289 COMPARED WITH TRIMETHOPRIM-SULFAMETOXAZOL FOR THE TREATMENT OF ACUTE PNEUMONIA BY PNEUMOCISTIS JIROVECI (PCP) IN PATIENTS WITH HIV / AIDS

IMMTECH INTERNACIONAL INC.,0 个研究点目标入组 0 人开始时间: 2006年6月5日最近更新: 2023年9月4日

试验速览

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•1. Proven or presumptive HIV infection.
•2. Male or female patients> 13 years of age and capable of swallowing tablets.
•3. Female patients who are not breastfeeding and without risk of pregnancy for one of the following reasons: a) postmenopausal at least one year, surgically sterile OR
•b) If she is of childbearing age, the patient should have a negative pregnancy test for human chorionic gonadotropin (hCG) and use a highly effective method of contraception during the course of the study. Sexual abstinence is acceptable. c) Do not try to get pregnant during the study period.
•4. Weight> 30kg.
•5. Signs and symptoms of PCP for at least 5 days.
•6. Pneumocystis jiroveci to be confirmed in BAL fluid or induced sputum sample.
•7. Candidate suitable for oral treatment.
•8. Alveolar oxygen - arterial (A-a) ≤ 45 mmHg to ambient air and partial pressure of oxygen (pO2) ≥ 60 mmHg.
•9. Platelet count> 50,000 x 10-9 / L, Hb> 80 g / L, neutrophil count> 0.75 x 10-9 and creatinine clearance> 30 mL / min.
•10. No more than 48 hours of previous treatment in the 7 days preceding treatment.
•11. The patient understood and voluntarily signed the informed consent before carrying out any specific procedure of the study. If the patient is a minor or mentally disabled, the legal guardian must sign the informed consent.

•. The patient does not want or can not discontinue the use of other medications with anti-PCP activity.
•2. Cachexia in relation to AIDS.
•3. Diarrhea and / or severe vomiting.
•4. History of hypersensitivity or serious or potentially fatal toxicity to TMP -SMX or other sulfonamides or pentamidine.
•5. Active use of illicit drugs that would compromise the patient´s participation in the study.
•6. Imminent respiratory insufficiency.
•7. AST and ALT> 3 times the upper limit of normal.
•8. History of pancreatitis.
•9. Severe PCP (gradient A-a> 45 mm Hg or pO2 <60 mm Hg with ambient air).
•10. Karnofsky score <20.
•11. Terminal HIV disease or life expectancy of less than 6 months.
•12. Acute concurrent pathological pulmonary state that can make difficult the evaluation of the response to treatment.
•13. Concomitant use of amphotericin B, ganciclovir, cyclosporin, warfarin, thiazide diuretics, phenytoin, methotrexate, leucovorin.
•14. Administration of systemic corticosteroids, within 14 days of admission to the study in high doses for 3 consecutive days or more.
•15. Pregnant or lactating woman.
•16. Unable to attend for any reason or do not want to, the follow-up visits required by the protocol.
•17. The patient was previously enrolled in the study.

发起方

IMMTECH INTERNACIONAL INC.,