Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Subjects 18 years of age or older
Item
Subjects 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Pregnancy, Childbearing Potential; Sterilization; Postmenopausal state; Contraceptive Use
Item
A female is eligible to enter and participate in this study if she is of: a) nonchildbearing potential (i.e. physiologically incapable of becoming pregnant including any female who is post- menopausal) b) child- bearing potential, has a negative pregnancy test (urine or serum) at screen and randomization, and agrees with one of the following: - Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for 1 week after completion or premature discontinuation from the study (to account for climination of the investigational drug) or, - Female sterilization; or, - Sterilization of male partner; or, - Contraceptive use, either hormonal, chemical or physical that has an accepted pregnancy rate of <1% per year as documented in the product labeling approved by regulatory agencies, or in absence of approved labelling, in peer reviewed studies
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C1999124 (UMLS CUI [5])
CD4+ lymphocyte count
Item
CD4+ lymphocyte count <100cells/ mm3 at the creening visit
boolean
C1277776 (UMLS CUI [1])
Documented history of HIV infection
Item
Documented history of HIV infection
boolean
C0019693 (UMLS CUI [1])
Positive HSV-2 serum antibody result
Item
Subjects with a positive HSV-2 serum antibody result, as determined by Western Blot or immunoblot at the screening visit
boolean
C1291921 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0005863 (UMLS CUI [2])
C0020985 (UMLS CUI [3])
C0545082 (UMLS CUI [4])
Recurrences of genital HSV; suppressive therapy
Item
Subjects experiencing 3 or more recurrences of genital HSV in the previous 12 months, or if the subject is on suppressive therapy for a herpes virus, then having experienced 3 or more recurrences of genital HSV per year in the period prior to the initiation of chronic suppressive therapy (chronic suppressive therapy is defined as therapy of at least 12 weeks duration)
boolean
C1274323 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205367 (UMLS CUI [2,2])
Signed and dated written informed consent
Item
A signed and dated written informed consent is obtained from the subject or subject's legally acceptable representative prior to study participation.
boolean
C0021430 (UMLS CUI [1])
Impaired renal function; creatinine clearance
Item
Subjects with impaired renal function defined as creatinine clearance <30 ml/min (calculated via central laboratory and/or with the Cockcroft- Gault formula)
boolean
C1565489 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C2711451 (UMLS CUI [1,3])
Iimpaired hepatic function; alanine transaminase (ALT)
Item
Subjects with impaired hepatic function defined as an alanine transaminase (ALT) level >5 times the upper limit of normal.
boolean
C0086565 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Thrombotic microangiopathies ; Thrombotic thrombocytopenia purpura; Hemolytic uremic syndrome
Item
Subjects who have or have had a diagnosis of thrombotic microangiopathies [e.g., thrombotic thrombocytopenia purpura (TTP) and/ or hemolytic uremic syndrome (HUS)]
boolean
C2717961 (UMLS CUI [1])
C0857305 (UMLS CUI [2])
C0019061 (UMLS CUI [3])
Hypersensitive to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir)
Item
Subjects known to be hypersensitive to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
boolean
C0020517 (UMLS CUI [1,1])
C0001367 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0209227 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0017066 (UMLS CUI [3,2])
HSV-2 isolates known to be resistent to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir)
Item
Subjects with HSV-2 isolates known to be resistent to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
boolean
C1989245 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0001367 (UMLS CUI [1,3])
C1989245 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0209227 (UMLS CUI [2,3])
C1989245 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0017066 (UMLS CUI [3,3])
Subjects with malabsortion or vomiting syndrome that might impair pharmacokinetics.
Item
Subjects with malabsorption or vomiting syndrome that might impair pharmacokinetics.
boolean
C0024523 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042963 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
Females contemplating pregnancy
Item
Females contemplating pregnancy within the duration of the study drug dosing period or 1 week after completion or premature discontinuation from the study
boolean
C0032961 (UMLS CUI [1,1])
C1277196 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Females who are pregnant and/ or nursing mothers
Item
Females who are pregnant and/ or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic anti- herpetic therapies
Item
Subjects receiving systemic anti- herpetic therapies. To be eligible for enrollment , subjects on anti- herpetic therapy must stop therapy at least 1 week prior to randomization.
boolean
C1579418 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Subjects with non- healed genital lesions at randomization.
Item
Subjects with non- healed genital lesions at randomization.
boolean
C0744369 (UMLS CUI [1,1])
C0750433 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2])
Systemic immunomodulators with anti-herpetic effects
Item
Subjects receiving systemic immunomodulators with anti-herpetic effects. To be eligible for enrollment, subjects receiving such therapy must stop therapy at least 1 week prior to randomization.
boolean
C1527392 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1579418 (UMLS CUI [1,3])
Subjects with active AIDS- indicator conditions, as defined by CDC Category C.
Item
Subjects with active AIDS- indicator conditions, as defined by CDC Category C.
boolean
C3888531 (UMLS CUI [1])
Subjects with lactose- intolerance enrolled at sites outside North and South America
Item
Subjects with lactose- intolerance enrolled at sites outside North and South America
boolean
C0022951 (UMLS CUI [1])