HIV-associated tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. HIV positive 2. Eligible and willing to start ART 3. CD4 150 cells/ul or less
Exclusion criteria
Exclusion criteria: 1. Age <18 years 2. Currently on TB treatment, or completed TB treatment in the last 3 months 3. First trimester of pregnancy, or desiring pregnancy in the next 6 months 4. Contraindication to efavirenze, based on current South African ART guidelines 5. Too sick to be managed in ambulatory care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 6 months after enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of hospital admission in first 6 months after enrolment 2. Time from enrolment to ART start 3. Proportion of patients retained in care, i.e. documented to have attended clinic for HIV care at 6 months (window: 150-240 days) after enrolment 4. Study-defined serious adverse events (particularly hepatotoxicity, hypersensitivity, peripheral neuropathy, and nephrotoxicity) in the intervention arm 5. Economic outcomes | — |
Countries
South Africa