Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy (REALITY)
Human Immunodeficiency Virus
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV
Eligibility Criteria
Inclusion Criteria:
- Aged 5 years or older
- Documented HIV infection by HIV ELISA or HIV rapid test
- Naive to ART
- CD4 T-cell count <100 cells/mm3 on blood test taken at screening for REALITY
- Results of screening haematology and biochemistry tests available and no contraindications to planned ART according to national guidelines
- Patient/carer provide informed consent (and children <18 years assent, as appropriate according to their age and knowledge of HIV status)
The lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by guidelines in older children.
No patient with a CD4 count above 100 cells/mm3 should have ART delayed in order to subsequently meet eligibility criteria. Rather, patients eligible for REALITY will be those testing HIV positive for the first time with a low CD4 count (i.e. those delaying presentation to care), or those who have defaulted before initiating ART and only return to care at an advanced stage of immuno-deficiency.
Exclusion Criteria:
- Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin
- Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study
- Ever known to have previously received single-dose nevirapine for prevention of mother-to-child transmission (mother or child).
Sites / Locations
- Moi University Clinical Research Centre
- KEMRI Wellcome Trust Research Programme
- University of Malawi
- Joint Clinical Research Centre, Fort Portal
- Joint Clinical Research Centre, Gulu
- Joint Clinical Research Centre, Mbale
- Joint Clinical Research Centre, Mbarara
- University of Zimbabwe Clinical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Antiretroviral Therapy
Opportunistic Infection (OI) Prophylaxis
Nutritional Support
Raltegravir twice daily for 12 weeks from antiretroviral therapy (ART) initiation in addition to 3 standard ARVs (2NRTIs/1NNRTI) compared with 3 standard ARVs
Immediate isoniazid/pyridoxine and cotrimoxazole, plus 12 weeks fluconazole, 5 days azithromycin and a single dose of albendazole compared with immediate cotrimoxazole (if not already taking this) in all patients plus (not malawi)isoniazid/pyridoxine after 12 weeks.
Supplementation with Ready to Use Supplementary Food (RUSF) for 12 weeks compared with supplementation for those with severe malnutrition as local practice.