Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding

NCT00803543 | Completed Results

• 1 other identifier: F080718009
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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 the amount of HSV in bodily secretions.

Conditions

HIV; HIV Infections

Keywords

HSV-2; Herpes Simplex; HSV Type 2; HIV; HIV/HSV; treatment experienced

Outcome Measures

Primary Outcomes (4)

• Herpes Simplex Virus Type 2 Recurrence

  Number of recurrences of genital herpes

  24 Weeks

• CD4 Count

  CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml

  24 weeks

• Number of Participants With an HIV Viral Load of <500 Copies/ml

  Number of participants with an HIV Viral Load of \<500 copies/ml at 24 weeks

  24 weeks

• Rate of Asymptomatic HSV-2 Genital Shedding

  Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.

  24 weeks

Study Arms (2)

Valacyclovir

ACTIVE COMPARATOR

This is the arm taking Valacyclovir

Drug: Valacyclovir

Placebo

PLACEBO COMPARATOR

This is the arm taking the placebo

Drug: Placebo

Interventions

Valacyclovir DRUG

500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks

Also known as: There are no other names

Valacyclovir

Placebo DRUG

Dosage: Two tablets once a day for 24 weeks

Also known as: There are no other names

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Community Care Building

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

HIV Infections; Herpes Simplex

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Small populations size. High level of patient withdrawal and loss to follow up.

Results Point of Contact

• Title: Nicholas Van Wagoner
• Organization: University of Alabama at Birmingham

nvw@uab.edu

205-934-2840

Study Officials

• Nicholas Van Wagoner, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 5, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 13, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)