A Phase 3 interventional study of Raltegravir and Fluconazole in Human Immunodeficiency Virus, sponsored by Anna Griffiths, MRC. Completed at 8 sites in 4 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Anna Griffiths, MRC · Phase 3, Interventional, and Treatment
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.
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 randomisations, each to address one of the potential approaches to reduce early mortality in adults and children initiating ART with low CD4, namely:
All participants will receive cotrimoxazole throughout the trial.
The primary objective of the trial is to identify effective, safe and acceptable interventions to reduce early mortality (all-cause) in HIV-infected adults, adolescents, and older children (5 years or more) initiating ART.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 1,805 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →This is the only study on the registry with Anna Griffiths, MRC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
Raltegravir twice daily for 12 weeks from antiretroviral therapy (ART) initiation in addition to 3 standard ARVs (2NRTIs/1NNRTI) compared with 3 standard ARVs
Drug: Raltegravir
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.
Drug: Fluconazole · Drug: Azithromycin · Drug: Albendazole · Drug: Isoniazid
Supplementation with Ready to Use Supplementary Food (RUSF) for 12 weeks compared with supplementation for those with severe malnutrition as local practice.
Dietary Supplement: Ready to Use Supplementary Food
400mg twice daily for the first 12 weeks only in addition to 3 standard ARVs
100mg once daily for 12 weeks
500mg once daily for 5 days
a single dose 400mg
300mg taken immediately in combination with cotrimoxazole
2x92g packets daily of high energy, low protein lipid-based paste for 12 weeks
Also known as: RUSF
All-cause mortality over the first 24 weeks after starting ART
Time frame: Week 24
48 week mortality (all-cause)
Time frame: Week 48
Safety
* serious adverse events * grade 4 adverse events * adverse events leading to modification of ART or other study drugs
Time frame: Week 0-48
Hospital inpatient episodes and total days admitted
Time frame: Week 0-48
Adherence to ART and acceptability of each strategy
Adherence to ART, OI drugs and RUSF will be assessed in all participants at each visit by pill counts and short nurse-administered questions. Every 12 weeks, a more detailed adherence questionnaire will be adminstered.
Time frame: Week 0-48
Endpoint relating to anti-infection intervention
Incidence of tuberculosis (TB), cryptococcal and candida disease, severe bacterial infections
Time frame: 0-48 weeks
Endpoint relating to anti-malnutrition intervention
BMI, weight and body fat assessed by bioimpedance analysis (BIA), height (in children) and grip strength
Time frame: 0-48 weeks
Endpoint relating to anti-HIV intervention
Changes in CD4 cell count
Time frame: 0-48 weeks
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→