HIV/AIDS Tuberculosis
Conditions
Interventions
ART only
TB medication + ART
Sponsors
Academic Medical Center, University of Amsterdam
Eligibility
Sex/Gender
All
Inclusion 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/µl. BMI <18 kg/m2 Ability to understand and provide written informed consent for the study.
Exclusion criteria
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 >1 month. History of using antiretroviral drugs (except short course pMTCT). 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 (e.g. household contacts of MDR-TB patients). Pregnant or breast-feeding. Cryptococcal meningitis (CrAG positive with neurologic symptoms). Creatinine clearance 30 per minute, heart rate>120bpm, temperature>39oC, 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ¿All-cause mortality in the first 24 weeks after initiation of ART | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary TB (based on available clinical and laboratory information including smear examination, culture, chest X-ray, and clinical assessment);unmasking TB ;sensitivity and specificity of clinical predictors (symptoms, signs, laboratory parameters) for incident unmasking TB;causes of death | — |
Countries
Gabon, Mozambique, South Africa, Uganda
Contacts
Public ContactFrank Cobelens
Professor of International Health
Outcome results
None listed