None listed
Conditions
Interventions
PHASE II Type of group
Patients will take a 50 mg dose of DB289 morning and evening after meals. If tolerated it is increased to a dose of 100 mg bid.
Group name:PHASE I Type of group
The first phase is a preliminary safety evaluation that is performed on 8 patients with a dose of 50 mg of DB289 morning and evening after meals.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 576/5000 Evidence of HIV infection documented by any ELISA authorized with an authorized confirmatory analysis. Intolerance to treatment with first-line therapy approved for NPC for this episode, that is, with trimethoprine / sulfamethoxazoi, or non-compliance with the requirements. NPC documented by morphological confirmation of P. organisms carinii in induced sputum, or bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open lung biopsy using standard staining methods for P. carinii organisms.
Exclusion criteria
Exclusion criteria: AIDS-related cachexia or weight <45 kg Female patients with the possibility of becoming pregnant Severe diarrhea or vomiting Active use of illegal drugs intravenously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exam, pulmonary signs / symptoms and chest x-ray. Measure:Estimate the efficacy and tolerance of DB289. Timepoints:21 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The incidence of adverse events of grade 3 or higher during the observation period. Measure:Tolerance and incidence of adverse events arising from treatment. Timepoints:21 day | — |
Countries
Peru
Outcome results
None listed