Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised controlled trial to investigate three methods to reduce early mortality in adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART) with severe immuno-deficiency. The three methods are:

(i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes

(ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks

(iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Griffiths, MRC
• Collaborators: Department for International Development, United Kingdom; Medical Research Council; PENTA Foundation; Wellcome Trust
• Treatments: Albendazole; Azithromycin; Fluconazole; Isoniazid; Raltegravir Potassium

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).