TB-IRIS NSAID Cox-2 Inhibitor Prevention Trial
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 03/31/2014 |
| Primero enviado: | 02/06/2014 |
| Inscripción estimada enviada: | 02/06/2014 |
| Publicado por primera vez: | 02/10/2014 |
| Última actualización enviada: | 04/01/2014 |
| Última actualización publicada: | 04/02/2014 |
| Fecha de inicio real del estudio: | 03/31/2014 |
| Fecha estimada de finalización primaria: | 03/31/2015 |
| Fecha estimada de finalización del estudio: | 03/31/2015 |
Condición o enfermedad
Intervención / tratamiento
Drug: Meloxicam 7.5 mg once-daily
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Placebo Comparator: Placebo 7.5 mg daily for 8 weeks Placebo 7.5 mg once-daily First 8 weeks of ART Only Control arm | |
| Experimental: Meloxicam 7.5 mg once-daily Meloxicam 7.5mg once-daily for 8 weeks | Drug: Meloxicam 7.5 mg once-daily Meloxicam 7.5mg daily for 8 weeks |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Males and non-pregnant females age 18 years of age or older - Evidence of HIV-1 infection - TB treatment (<2 weeks) and initiating EFV-based antiretroviral therapy as per the South African Department of Health Guidelines - Living in the study site catchment area and having had a known address for more than 3 months - Written informed consent Exclusion Criteria: - History of aspirin sensitivity and allergies to other NSAIDs - Current or recent use (<3 months) of aspirin, NSAIDs, or anticoagulants such as warfarin. - Current or recent use of corticosteroid therapy - History of gastro-intestinal bleeding or peptic ulcer - History of cardiovascular thrombotic events (myocardial infarction or stroke), hypertension, or congestive heart failure - Severe renal impairment as evidenced by creatinine clearance <50 (Cockcroft- Gault Formula) - Severe liver disease (ALT > five times upper limit of normal) - Presence of a medical condition likely to result in death within 6 months from start of ART. These conditions include suspected or CNS lymphoma, PMLE and disseminated visceral Kaposi's sarcoma - Cognitive disorder(s) that could impair ability to comply with study requirements, as determined by the study physician - Karnofsky performance score <60 |
Salir
Medidas de resultado primarias
1. Incidence of TB IRIS [6 months]
Medidas de resultado secundarias
1. Proportion discontinuing Meloxicam due to adverse event [6 months]
2. The proportion of patients in each arm with the following indicators of TB-IRIS severity/quality of life (QOL) (degree of pain or discomfort >III [6 months]
3. The proportion of patients with local or disseminated suppuration/abscess of any site, unscheduled clinic visits, hospitalizations, missed more than a day at work, etc [6 months]
