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Herpes Research

Participating in a Clinical Trial

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Is it the right choice for you?

Recently, we wrote about a recent clinical trial for the drug ASP2151. Developed by Astellas Pharmaceuticals, ASP2151 may increase the time between outbreaks and may provide an alternative treatment for those who have developed HSV drug resistance or are non-responsive to current medications. Recently, we learned all participants in phase II of the trial have completed the study and researchers will conduct a data review in October. Hopefully, we will have more to share in the future.

However, did you know ASP2151 already appears promising by almost completing the second phase of the clinical trial process? According to CenterWatch, a clinical trial listing service, only a third of experimental drugs finish phase I and phase II successfully. If you have ever wondered why the participants in this trial or any trial choose to participate or just wondered what happens during a trial, this article is for you. 

Clinical trials test a drug’s safety and efficacy in humans. Phase I of a trial is done to assess a drug’s safety. Participants in this phase are usually healthy volunteers. This stage enables researchers to develop a safe dosage for the drug or treatment and identify side effects.

Phase II of a trial helps to further identify side effects and evaluate effectiveness, depending on the condition. For some interventions only phase III studies are able to assess effectiveness. Participants in this phase usually have the disease or condition the experimental drug or trParticipating in a Clincal Trialeatment would address.

Phase III could be characterized as the expansion of phase II. In this phase a larger number of participants are used and the drug is further evaluated for effectiveness. During this phase the drug is compared to currently available treatments. If no treatment is currently available for the disease or condition, the experimental drug is compared to a placebo—an inactive substance that has no medication. Those who are randomly chosen to get the placebo are unaware that they are in fact taking it and not the actual drug, although all participants are told that they may get the drug or the placebo. If the drug is not safe, you would be fortunate to be in the placebo group.

If the drug is successful in phase III and receives clearance from the Food and Drug Administration (FDA), further study may be done once it is on the market to gather more information regarding the drug’s benefits and risks. This is considered Phase IV.       

So why participate in a clinical trial? For one, testing in animals can only tell you so much about how the drug may work in humans. By participating in a clinical trial you provide researchers with vital information that will eventually help many people. Additionally, being paid for participation doesn’t hurt either. For those who considering trial participation,, a registry of federally and privately supported clinical trials from the National Institutes of Health, lists the following benefits and risks of trial participation:

Benefits for participants:

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading healthcare facilities during the trial.

Risks for participants:

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What if the drug or treatment fails during the trial and never makes it to market, would my time be wasted? No. Throughout the clinical trial data is gathered and reviewed. Even if the drug never makes it to market the data gathered may prove invaluable for future studies or for re-evaluation of the failed drug or treatment. It is better to have the drug fail during trials than to make it to market and have unsuspected adverse events occur in patients receiving the treatment or drug. Whether the treatment makes it to market or not your participation provides researchers with vital information that may benefit many.

Considering trial participation? You may want to speak with others who participated in trials previously and learn what their first hand experiences entailed. Additionally, you may want to visit and for further information on clinical trials before making your final decision.


You Are Not Alone

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Latest WHO estimates indicate more than half a billion have HSV-2

One sentiment that we often hear at the Herpes Resource Center from people newly diagnosed with genital herpes is this: “I feel like I’m alone.” As a recently released report by the World Health Organization (WHO) indicates, this couldn’t be further from the truth. According to WHO estimates, more than half a billion people worldwide are infected with herpes simplex virus 2—a figure that amounts to about 16 percent of the total global population.

The WHO report is the first to systematically examine the global scope of HSV-2 infection. Data gathered from hundreds of studies determined You are not aloneprevalence and incidence of HSV-2 in 12 global regions. In the final analysis, the report estimated that approximately 536 million people between the ages of 15 and 49 were living with HSV-2 in 2003.

Overall, more women than men were infected with HSV-2, with 315 million women compared to 221 million men. However, in some regions, including the Pacific, southeast Asia and south Asia for older groups and north Africa and the Middle East for younger groups, prevalence rates for men were higher. Prevalence also increased with age, with a peak in the 34-39 age group.

While prevalence was generally higher in developing countries, there were some exceptions. Among these was North America, with a relatively high prevalence. The lowest prevalence among the 12 regions was Western Europe, with prevalence reaching a maximum of 18 percent among women and 13 percent among men. The region with the highest was sub-Saharan Africa, with prevalence reaching a maximum of 70 percent among women and 55 percent among men.

Incidence rates for 2003 reflect the same gender difference. Of the estimated 23.6 million new HSV-2 infections in 2003, approximately 12.8 were women and 10.8 million were men. While gender differences in infection rates have been found in previous studies, the authors of the WHO report indicate that the reasons for this are unclear. They suggest that, as with other sexually transmitted infections, anatomical differences may leave women more susceptible to infection. Additionally, they indicate that the distribution of sexual risk behaviors between men and women may also contribute to this uneven distribution.

While this first attempt to measure global herpes prevalence and incidence is valuable, the data necessarily reflect the wide variability of studies across the globe. As the authors state, “No matter how sophisticated the statistical methods used to produce them, estimates are only as good as the data from which they are calculated.” Nevertheless, these estimates provide a framework to develop public health policy and target educational and prevention efforts across the globe.

Herpes: By the Numbers

563  million
people infected with HSV-2 worldwide
50 million
people with HSV-2 in the United States.
90% The approximate percentage of the 50 million people in the U.S. who have genital herpes that are unaware of, or don’t recognize, their infection.
50-80% of the U.S. adult population with HSV-1, the most common cause of oral herpes.
10-20% The percent of days that HSV-2 can be found in the genital tract of those with the infection.
48% The percentage reduced risk of transmission to an uninfected partner if the partner with HSV-2 takes valacyclovir daily as suppressive therapy.
The number of weeks it takes for detectable antibodies to develop (and be detected by a type-specific serological test).
The number of hours after an appearance of a lesion that a culture test can be done for it to be most reliable.
1 (day)
The shortest dose of episodic treatment that one needs to take (famciclovir 1000 mg orally twice daily for 1 day at the first sign of an outbreak).
Less than 0.1% The percent of babies born in the United States each year that contract neonatal herpes.
The decrease in the risk of transmission by knowing that your partner has genital herpes.
The percent of people with newly acquired genital herpes who have had only one partner in the last month prior to HSV-2 acquisition.



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