A Randomized, Placebo Controlled, Double Masked Phase IB Study Evaluating the Safety and Antiviral Activity of Aprepitant, a Neurokinin-1 Receptor Antagonist in HIV-1 Infected Adults
2011

Study on Aprepitant for HIV Treatment

Sample size: 30 publication 10 minutes Evidence: moderate

Author Information

Author(s): Pablo Tebas, Florin Tuluc, Jeffrey S. Barrett, Wayne Wagner, Deborah Kim, Huaquing Zhao, René Gonin, James Korelitz, Steven D. Douglas, Andrew D. Badley

Primary Institution: University of Pennsylvania

Hypothesis

Does aprepitant, a neurokinin-1 receptor antagonist, have safety and antiviral activity in HIV-infected adults not receiving antiretroviral therapy?

Conclusion

Aprepitant showed biological activity but no significant antiviral activity in HIV-infected adults.

Supporting Evidence

  • Aprepitant was safe in HIV-infected patients not receiving antiretroviral therapy.
  • Adverse events were more common in the aprepitant-treated groups.
  • No significant changes in HIV RNA viral load were observed.

Takeaway

This study tested a drug called aprepitant to see if it could help people with HIV. It was safe but didn't really help lower the virus levels.

Methodology

A phase IB randomized, placebo-controlled, double-masked study with HIV-infected adults not on antiretroviral therapy, receiving aprepitant or placebo for 14 days.

Potential Biases

Potential bias due to the small number of participants and the nature of the study design.

Limitations

The study had a small sample size and a short duration of treatment.

Participant Demographics

63% male, 37% white, mean age 43 years.

Statistical Information

P-Value

p=0.042

Confidence Interval

95% CI for changes in viral load: Low - (−0.24,+0.20), High - (−0.21,+0.10), PL - (−0.08,+0.16)

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0024180

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