This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
REALITY was a completed phase 3 randomized treatment trial evaluating interventions to reduce early mortality among HIV-infected adults and children starting antiretroviral therapy.
| Feature | REALITY |
|---|---|
| NCT ID | NCT01825031 |
| Acronym | REALITY |
| Title | Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy |
| Status | COMPLETED |
| Start date | 2013-06 |
| Primary completion date | 2016-03 |
| Allocation | RANDOMIZED |
| Design model | FACTORIAL |
| Masking | NONE |
| Primary purpose | TREATMENT |
2. Clinical Question
Population
HIV-infected adults and children starting antiretroviral therapy.
Interventions
Raltegravir, fluconazole, azithromycin, albendazole, isoniazid, and ready to use supplementary food.
Comparator
Randomized comparison groups within the factorial treatment design.
Primary question
What is the effect of the randomized strategies on all-cause mortality over the first 24 weeks after starting ART?
3. Trial Design
Study interventions
- Raltegravir
- Fluconazole
- Azithromycin
- Albendazole
- Isoniazid
- Ready to Use Supplementary Food
Factorial structure
The registry identifies the study as using a factorial design, allowing multiple intervention questions to be evaluated within the randomized framework.
4. Endpoints
| Endpoint | Definition | Time frame |
|---|---|---|
| All-cause mortality | All-cause mortality over the first 24 weeks after starting ART | Week 24 |
5. Planned Analysis
The ClinicalTrials.gov record identifies all-cause mortality over the first 24 weeks after starting ART as the primary endpoint. No statistical analyses are posted on ClinicalTrials.gov.
A mortality endpoint is typically evaluated using event-count comparisons between randomized groups. Depending on the prespecified analysis plan, methods may include risk comparisons, time-to-event methods, or regression models accounting for the randomized design.
6. Statistical Methodology
Factorial trial design
A factorial design evaluates multiple interventions within a single randomized trial structure. The statistical goal is to estimate intervention effects while considering the way treatment factors are assigned.
Interpretation depends on the prespecified treatment comparisons, interaction assumptions, and analysis plan.
Mortality endpoints
All-cause mortality is a binary clinical event that can also be analyzed as a time-to-event outcome when follow-up time and censoring information are incorporated.
7. Statistical Methods Explained
Why use a factorial design?
A factorial design can allow investigators to study more than one intervention question efficiently. Interpretation requires understanding which treatment effects were prespecified and whether interactions between interventions were considered.
Why is all-cause mortality a useful endpoint?
All-cause mortality counts deaths from any cause, reducing the need to classify cause-specific outcomes and providing a direct clinical endpoint.
How are mortality outcomes commonly compared?
Mortality can be summarized as proportions at a fixed time point or analyzed over time using survival methods that account for censoring.
Why does randomization matter?
Randomization helps balance known and unknown prognostic factors between groups, supporting unbiased treatment comparisons.
8. Limitations
- The ClinicalTrials.gov record does not report posted statistical analyses or numerical outcome results.
- Without posted analyses, treatment effect estimates and uncertainty measures cannot be summarized from the registry record.
- Factorial trials require careful interpretation of interaction between intervention effects.
- Generalizability depends on the enrolled population and study setting.
9. Why This Trial Matters Statistically
| Concept | How it appears in REALITY |
|---|---|
| Randomization | Randomized phase 3 treatment comparison |
| Factorial design | Registry-defined factorial study model |
| Clinical endpoint | All-cause mortality over 24 weeks |
| Time frame | Week 24 primary endpoint assessment |
10. Related Tutorials
Learn more about the methods used in this trial:
11. Related Calculators
12. Sources
- ClinicalTrials.gov record: NCT01825031
- PubMed record
- PubMed record
- PubMed record
- PubMed record