Trial Effect in HIV Clinical Trials
Author Information
Author(s): Menezes Prema, Miller William C., Wohl David A., Adimora Adaora A., Leone Peter A., Eron Joseph J. Jr.
Primary Institution: University of North Carolina at Chapel Hill
Hypothesis
Does participation in clinical trials lead to better clinical outcomes for HIV patients compared to routine care?
Conclusion
A clear clinical trial effect on suppression of HIV replication was observed in the early HAART period but not in the current period.
Supporting Evidence
- 78% of patients achieved virologic suppression.
- Trial participants were 16% more likely to achieve virologic suppression.
- In the early HAART period, trial participants had a significantly higher rate of virologic suppression.
Takeaway
People in clinical trials for HIV treatment often do better than those getting treatment outside of trials, especially in the past. But now, the difference isn't as clear.
Methodology
Compared virologic suppression among HIV patients starting HAART in clinical trials versus routine care using risk ratios.
Potential Biases
Potential unmeasured confounders could mask or inflate a trial effect.
Limitations
The study was conducted at a single center, and one-third of the cohort was missing outcome data.
Participant Demographics
Of 738 participants, 30.6% were women, 61.7% were black, and 34% initiated therapy in a clinical trial.
Statistical Information
P-Value
p<0.001
Confidence Interval
95%CI 1.06, 1.27
Statistical Significance
p<0.001
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website