Status:
COMPLETED
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV
HIV Infections
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 t...
Detailed Description
Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes "cold sore...
Eligibility Criteria
Inclusion
- 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
- 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 other condition which, in the opinion of the principal investigator, may compromise the subject's ability to follow study procedures and complete the study.
- Participants with active bacterial STDs (sexually transmitted diseases) may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00803543
Start Date
January 1 2009
End Date
April 1 2014
Last Update
July 13 2017
Active Locations (1)
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1
Community Care Building
Birmingham, Alabama, United States, 35294