Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT00527618
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Documented HIV-1 seropositive
* Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
* Detectable HIV-1 plasma viral load
* HSV-2 seropositive as determined by western blot
* Not intending to move out of the area for the duration of study participation
* Willing and able to provide independent written informed consent
* Willing and able to undergo clinical evaluations
* Willing and able to take study drug as directed
* Willing and able to adhere to follow-up schedule
Exclusion Criteria:
* Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir
* Planned open label use of acyclovir, valacyclovir, or famciclovir
* History of evidence of CMV disease
* Known medical history of seizures
* Known renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl
* AST or ALT greater than 3 times upper limit of normal
* Hematocrit less than 30 %
* Neutropenia, defined as absolute neutrophil count less than 1000
* Thrombocytopenia, defined as platelet count less than 75,000
* History of thrombotic microangiopathy
* For women, pregnancy as confirmed by a urine pregnancy test
* Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00527618
Study Brief:
Protocol Section:
NCT00527618