None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with DB289 100 mg BID PO for 14 days. After this it will be treated with DB289 Placebo BID PO for 7 more days. Concomitantly this group will receive TMP / SMX Placebo TID PO for 21 days.
Group name:GROUP 2 Type of group
This group will be treated with DB289 Placebo BID PO for 21 days. Concomitantly, this group will receive TMP / SMX at a dose of 15-20 mg of TMP / kg as the total dose, which will be divided every 8 hours, PO for 21 days.
Sponsors
IMMTECH INTERNACIONAL INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: . 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Where clinical success will be evaluated which is defined as survival and lack of additional treatment against PCP in addition to the study medication. Measure:Proportion of patients with clinical success at the end of treatment for the population with modified intention to treat (lTTm). Timepoints:End of treatment: Day 22. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Where clinical success will be evaluated which is defined as survival and lack of additional treatment against PCP in addition to the study medication. And sustained clinical success which is defined as survival and lack of additional treatment against PCP in addition to the study medication until the evaluation of day 42, will also be evaluated. Measure:Proportion of patients with clinical success at the end of treatment in the population per protocol. Sustained clinical success rate at the end of the study in the populations by protocol and with the intention to treat modified (lTTm). Timepoints:Follow-up evaluation on day 42. ; Outcome name:Physical examination and vital signs. Laboratory tests: Hematology and serum chemistry panels. 12-lead ECG. Measure:Safety of the treatment. Timepoints:Physical examination and vital signs, laboratory tests: Before treatment and on days 5, 8 and 14, at the end of treatment and at the follow-up on day 42. Panels of hematology and serum chemistry. 12-lead ECG: Before treatment and on days 8 and 14, at the end of treatment and at follow-up on day 42. ; Outcome name:Criterion 1: Clinical evaluation: Where clinical success will be evaluated which is defined as survival and lack of additional treatment against PCP in addition to the study medication. This definition will be applied to subgroups of patients defined by: Gender, age, BMI, research center and country, previous or concurrent antiretroviral treatment, previous PCP, previous prophylaxis for PCP, CD4 count at the baseline visit and other relevant factors. Criterion 2: Clinical determination of the appearance of a lung infection by an unidentified pathogen at the baseline visit. A sputum culture and imaging tests should be performed. Criterion 3: The Van Elteren Test will be used to evaluate the differences between the treatment subgroups regarding the symptoms and signs from the baseline | — |
Countries
Peru, United States
Outcome results
None listed