Clinical trial NCT00005663: A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
Official title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Herpes Simplex
HIV Infections
Herpes Genitalis
Keywords: Herpes Simplex
Antiviral Agents
Anus Diseases
Herpes Genitalis
Recurrence
valacyclovir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.

Detailed description: Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are HIV-positive.
* Have herpes simplex virus (HSV) 2.
* Have received combination anti-HIV therapy for at least 2 months before entering the study.
* Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
* Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.)

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have blood vessel disease.
* Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
* Are unable to take medications by mouth.
* Have non-healed sores on the anus or genitals at beginning of study.
* Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
* Are using interferon. Patients receiving interferon must stop interferon before beginning the study.
* Have kidney or liver problems.
* Are pregnant or breast-feeding.
* Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: Los Angeles
country: United States
facility: Kraus Med Partners
state: California
city: San Francisco
country: United States
facility: ViRx Inc
state: California
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Fort Lauderdale
country: United States
facility: Healthnet Institute
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Ctr
state: Florida
city: Indianapolis
country: United States
facility: Indiana Univ School of Medicine / Dept of Infect Dis
state: Indiana
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
city: Hackensack
country: United States
facility: Advanced Biomedical Research Inc
state: New Jersey
city: Charlotte
country: United States
facility: Nalle Clinic / Clinical Research Dept
state: North Carolina
city: Raleigh
country: United States
facility: Wake County Dept of Health
state: North Carolina
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Providence
country: United States
facility: Dr Alvan Fisher
state: Rhode Island
city: Houston
country: United States
facility: Baylor College of Medicine / Dept of Medicine
state: Texas
city: Richmond
country: United States
facility: Richmond AIDS Consortium
state: Virginia
city: Seattle
country: United States
facility: Univ of Washington Virology Research Clinic
state: Washington
city: Edmonton
country: Canada
facility: Dr Barbara Romanowski
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Science Ctr
state: Ontario
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
city: Ste Foy
country: Canada
facility: Centre De Recherche En Infectiologie
state: Quebec
Study officials:
References: