N/A
Completed N=103
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
Source: ClinicalTrials.gov NCT00803543 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Herpes Simplex Virus Type 2 Recurrence — 0; 0 Recurrence
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Herpes Simplex Virus Type 2 Recurrence |
0; 0 | — |
| PRIMARY CD4 Count |
536; 627.5 | — |
| PRIMARY Number of Participants With an HIV Viral Load of <500 Copies/ml |
38; 20 | — |
| PRIMARY Rate of Asymptomatic HSV-2 Genital Shedding |
0.0009; 0.0001 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00803543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.