Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding (NCT00803543) | Clinical Trial Compass
CompletedNot Applicable
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
United States103 participantsStarted 2009-01
Plain-language summary
The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 19 years or older
* HSV-2 (Herpes simplex virus type 2) seropositive as determined by HerpeSelect-2 ELISA
* Documented HIV-1 seropositive
* Currently receiving HAART for 3 months or longer
* CD4 (cluster of differentiation 4) count 350 or greater
* Women of child bearing potential must agree to use acceptable contraceptive measures during the entire conduct of the study. Acceptable contraceptive methods include one or more of the following: oral hormonal contraceptives, injectable hormonal contraceptives, transdermal hormonal contraceptives, IUD (intrauterine device), diaphragm or cervical cap.
* Willing and able to provide written informed consent, undergo clinical evaluations, and take study drug as directed
Exclusion Criteria:
* History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.
* Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
* Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.
* Medical history of seizures
* Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl
* AST (aspartate aminotransferase) or ALT (alanine aminotransferase) over 5 times uper limit of normal
* History of thrombotic microangiopathy
* For women, pregnancy as confirmed by a urine or serum pregnancy test.
* Any ot…
What they're measuring
1
Herpes Simplex Virus Type 2 Recurrence
Timeframe: 24 Weeks
2
CD4 Count
Timeframe: 24 weeks
3
Number of Participants With an HIV Viral Load of <500 Copies/ml