Status:
COMPLETED
Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy
Lead Sponsor:
Anna Griffiths, MRC
Collaborating Sponsors:
Department for International Development, United Kingdom
Wellcome Trust
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief 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-...
Detailed Description
REALITY is a open-label randomised trial of 1800 adults, adolescents and children aged 5 years or more with low CD4 counts about to initiate ART. The trial will have a factorial design with 3 randomi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
1805 Patients enrolled
Trial Details
Trial ID
NCT01825031
Start Date
June 1 2013
End Date
March 1 2016
Last Update
April 20 2016
Active Locations (8)
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1
Moi University Clinical Research Centre
Eldoret, Kenya
2
KEMRI Wellcome Trust Research Programme
Kilifi, Kenya
3
University of Malawi
Blantyre, Malawi
4
Joint Clinical Research Centre, Fort Portal
Fort Portal, Uganda