Status:
TERMINATED
Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment
Lead Sponsor:
Prof JMA Lange
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
HIV Infection
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study investigates the prevention of early mortality in patients initiating antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB reside. Many published stud...
Eligibility Criteria
Inclusion
- Aged \> 18 years old
- HIV-1 positive
- Eligible for antiretroviral treatment with CD4 T cell count \< 50 cells/μl
- BMI \< 18
Exclusion
- Patients with smear-positive pulmonary TB
- Patients who fulfill the diagnostic criteria for smear-negative pulmonary or extrapulmonary TB (http://www.who.int/tb/publications/2006/tbhiv\_recommendations.pdf ).
- Previous TB treatment (history of TB medication for \> 1 month
- History of using antiretroviral drugs
- Symptomatic known underlying liver disease or transaminases \> 5x upper limit of normal
- Known or suspected drug resistance to more than one first-line TB drug according to WHO criteria but excluding HIV infection (e.g. household contacts of MDRTB patients)
- Pregnant or breast-feeding
- Patients with cryptococcal meningitis (CrAG positive with neurologic symptoms)
- Patients with other severe (opportunistic) disease such as disseminated KS, malignant lymphoma, toxoplasmosis who may not be able to tolerate anti-TB medication or require other specific therapy
- Patients with danger signs (respiratory rate \> 30 per minute, heart rate \> 120bpm, temperature \> 39oC, and unable to ambulate)
- Taking other potentially life-saving medications (e.g. for other OIs, or immunosuppressants) that are incompatible with anti-TB chemotherapy or ART
- Unable to swallow TB medications
- Unable to follow-up at the clinic for regularly scheduled follow-up (e.g. too far from clinic)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01417988
Start Date
August 1 2011
End Date
June 1 2013
Last Update
February 17 2014
Active Locations (3)
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1
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, Gabon
2
Ministry of Health -Provincial Heatlh Directorate of the Sofala Province (Direcção Provincial de Saúde de Sofala DPSS)
Beira, Mozambique
3
Infectious Diseases Institute University Makarere
Kampala, Uganda