Evaluating Prosaptide for HIV-Associated Sensory Neuropathies
Author Information
Author(s): Scott R. Evans, David M. Simpson, Douglas W. Kitch, Agnes King, David B. Clifford, Bruce A. Cohen, Justin C. McArthur
Primary Institution: Harvard School of Public Health
Hypothesis
To examine the efficacy and safety of Prosaptide™ (PRO) for the treatment of painful HIV-associated sensory neuropathies (HIV-SN).
Conclusion
6-week treatment with PRO was safe but not effective at reducing HIV-associated neuropathic pain.
Supporting Evidence
- 237 participants were randomized in the study.
- The study was stopped after a planned futility analysis.
- There were no between-group differences in the frequency of adverse events.
- The 6-week mean changes in pain scores were not statistically significant.
- Use of an electronic diary for pain recording was novel but did not reduce variability in pain scores.
Takeaway
This study tested a new treatment for pain caused by HIV but found that it didn't help people feel better.
Methodology
A randomized, double-blind, placebo-controlled, multicenter study with participants receiving either Prosaptide or placebo for six weeks.
Limitations
The study was stopped after a planned futility analysis, indicating low probability of achieving statistical significance.
Participant Demographics
The study included 237 adults with neurologist-confirmed painful HIV-SN, predominantly male (92%).
Digital Object Identifier (DOI)
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