In August 1999, the National Institute of Allergy and Infectious Diseases began a phase III clinical trial on the drug Acyclovir. The study was conducted until April 2008 so as to see the long-term effects of the drug. The purpose of the study was to test the efficacy of oral Acyclovir in treating infants for herpes simplex virus (HSV) specifically on their skin, eyes, and mouth.1
To be enrolled in this study, the participant must firstly be less than 28 days old, either gender, and have herpes simplex virus of the skin, eyes, or mouth confirmed by a viral culture. The participant must have cerebrospinal fluid with normal white blood cell count (<220 mg/dL. CT scans, MRI scans, and cerebrospinal fluid polymerase chain reaction lab tests will …show more content…
This study focuses on HSV presenting in the skin, eyes, or mouth which is less severe. However, HSV of the skin, eyes, or mouth can progress to more severe diseases such as disseminated HSV or HSV of the central nervous system. Mortality rates of untreated disseminated HSV is 85% and mortality rates of untreated HSV of the central nervous system is 50%. Because the severe cases of HSV are so dangerous, it is imperative that treatment of HSV of the skin, eyes, and mouth prevents progression of the disease. If long-term treatment with Acyclovir is found to successfully suppress HSV of the skin, eyes, and mouth in infants, then further studies can be done to see its efficacy with the more severe diseases. This study will also periodically test the infants for presence of HSV in the cerebrospinal fluid. If the results show no progression of the disease into the cerebrospinal fluid, it provides evidence that Acyclovir can provide long-term suppression of …show more content…
Acyclovir is taken orally, and so must travel through the gastrointestinal tract and liver before entering the central plasma compartment. After absorption into the plasma, Acyclovir will reach a maximum concentration, or bioavailability, of 9.8 mcg/mL. Once in the plasma, it will bind to plasma proteins with a wide range of efficiency, 9-33%. Acyclovir is metabolized to multiple metabolites, the major one being 9-carboxymethoxymethylguanine. It has a half-life of 2.5 hours and so in that time, half of the given concentration will have been eliminated. Acyclovir has a creatinine clearance test value of greater than 80 mL/min. there are some adverse reactions to be aware of when administering Acyclovir as it can cause increased risk of renal tubular damage and renal failure if given intravenously for over an hour. If the patient is immunocompromised, there have been cases of thrombotic thrombocytopenic purpura. If the patient has had renal disease in the past, they must be careful to stay hydrated or dehydration could impair kidney function. Patients with a history of neurologic disorders, renal or hepatic abnormalities, or hypoxia should be careful when taking Acyclovir. Since renal function declines with age, the elderly should also be cautious when taking Acyclovir. Patients taking nephrotoxic drugs or Probenecid should probably not take Acyclovir. Given
To be enrolled in this study, the participant must firstly be less than 28 days old, either gender, and have herpes simplex virus of the skin, eyes, or mouth confirmed by a viral culture. The participant must have cerebrospinal fluid with normal white blood cell count (<220 mg/dL. CT scans, MRI scans, and cerebrospinal fluid polymerase chain reaction lab tests will …show more content…
This study focuses on HSV presenting in the skin, eyes, or mouth which is less severe. However, HSV of the skin, eyes, or mouth can progress to more severe diseases such as disseminated HSV or HSV of the central nervous system. Mortality rates of untreated disseminated HSV is 85% and mortality rates of untreated HSV of the central nervous system is 50%. Because the severe cases of HSV are so dangerous, it is imperative that treatment of HSV of the skin, eyes, and mouth prevents progression of the disease. If long-term treatment with Acyclovir is found to successfully suppress HSV of the skin, eyes, and mouth in infants, then further studies can be done to see its efficacy with the more severe diseases. This study will also periodically test the infants for presence of HSV in the cerebrospinal fluid. If the results show no progression of the disease into the cerebrospinal fluid, it provides evidence that Acyclovir can provide long-term suppression of …show more content…
Acyclovir is taken orally, and so must travel through the gastrointestinal tract and liver before entering the central plasma compartment. After absorption into the plasma, Acyclovir will reach a maximum concentration, or bioavailability, of 9.8 mcg/mL. Once in the plasma, it will bind to plasma proteins with a wide range of efficiency, 9-33%. Acyclovir is metabolized to multiple metabolites, the major one being 9-carboxymethoxymethylguanine. It has a half-life of 2.5 hours and so in that time, half of the given concentration will have been eliminated. Acyclovir has a creatinine clearance test value of greater than 80 mL/min. there are some adverse reactions to be aware of when administering Acyclovir as it can cause increased risk of renal tubular damage and renal failure if given intravenously for over an hour. If the patient is immunocompromised, there have been cases of thrombotic thrombocytopenic purpura. If the patient has had renal disease in the past, they must be careful to stay hydrated or dehydration could impair kidney function. Patients with a history of neurologic disorders, renal or hepatic abnormalities, or hypoxia should be careful when taking Acyclovir. Since renal function declines with age, the elderly should also be cautious when taking Acyclovir. Patients taking nephrotoxic drugs or Probenecid should probably not take Acyclovir. Given