Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00495651 | Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO) | PHASE3 | COMPLETED | 2,073 | — | — | Mar 1, 2008 | Jan 1, 2015 | Jun 3, 2015 | 9 | Côte d’Ivoire |
* Severe HIV-related disease are defined as AIDS-defining diseases, non-AIDS- defining malignancies, and non-AIDS-defining invasive bacterial diseases * Invasive bacterial diseases are defined as: bacteremia, or bacterial infection of any solid organ or aseptic cavity (eg: pneumonia, pleurisy, meningitis,pyomyositis, pyelonephritis, prostatitis, orchitis, epididymitis, salpingitis, endometritis, endocarditis, cholecystitis, visceral abscesses).
| Arm | Type | Description |
|---|---|---|
| I | ACTIVE_COMPARATOR | Standard of care |
| II | EXPERIMENTAL | Standard of care+Isoniazid Prophylaxis: |
| III | EXPERIMENTAL | Early Antiretroviral therapy |
| IV | EXPERIMENTAL | Early Antiretroviral therapy + Isoniazid prophylaxis |
| Name | Type | Description |
|---|---|---|
| Antiretroviral medications | DRUG | Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed. |
| Antiretroviral medications+Isoniazid prophylaxis | DRUG | * Antiretroviral initiation at any time during the trial if at least one 2009 WHO-recommended criterion for starting ART is observed. * Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion |
Inclusion Criteria: * HIV-1 or HIV-1 + HIV-2 infection * Age \>18 years * No ongoing active tuberculosis * Home address in any district of the greater Abidjan area * Written informed consent before any clinic visit or laboratory test * Clinical and immunologic status:CD4 counts \<800/mm3 and no cri...