Prevention of early mortality by presumptive TB treatment [retrospectively registered]

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201110000301425
• Date of registration: 06/06/2011
• Primary sponsor: Academic Medical Center, University of Amsterdam
• Public title: Prevention of early mortality by presumptive TB treatment [retrospectively registered]
• Scientific title: Prevention of early mortality by presumptive TB treatment in HIVinfected
• Date of first enrolment: 2011-10-20
• Target sample size: 334
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000301425
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Stratified block randomization,; Central electronic randomization,

Countries of recruitment

South Africa

Contacts

• Name: Frank Cobelens
• Affiliation: Professor of International Health

• Name: Frank Cobelens
• Affiliation: Professor of International Health

Key inclusion & exclusion criteria

Inclusion criteria: At least 18 years of age.
HIV-1 infected as documented and confirmed by a licensed rapid test for HIV-1 antibodies or HIV-1 antibody ELISA.
Eligible for antiretroviral treatment with CD4 T cell count`50 cells/?l.
BMI `18 kg/m2
Ability to understand and provide written informed consent for the study.

Exclusion criteria: Patient has smear-positive pulmonary TB.
Fulfills the diagnostic criteria for smear-negative pulmonary or extrapulmonary TB.
Previous TB treatment (history of TB medication for b1 month.
History of using antiretroviral drugs (except short course pMTCT).
Symptomatic known underlying liver disease or transaminases b5x upper limit of normal.
Known or suspected drug resistance to more than one first-line TB drug (e.g. household contacts of MDR-TB patients).
Pregnant or breast-feeding.
Cryptococcal meningitis (CrAG positive with neurologic symptoms).
Creatinine clearance `=50 ml/minute
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.
Unresolved danger signs (respiratory rateb30 per minute, heart rateb120bpm, temperatureb39oC, unable to ambulate)(requiring empiric antibiotics).
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 visits (e.g. too far from clinic).


Age minimum: 18 Year
Age maximum: 110 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
Tuberculosis
null

Primary Outcome(s)

? All-cause mortality in the first 24 weeks after initiation of ART

Secondary Outcome(s)

causes of death

Pulmonary TB (based on available clinical and laboratory information including smear examination, culture, chest X-ray, and clinical assessment)

sensitivity and specificity of clinical predictors (symptoms, signs, laboratory parameters) for incident unmasking TB

unmasking TB

Source(s) of Monetary Support

EDCTP