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.

Condition	Treatment or Intervention	Phase
Herpes Simplex HIV Infections Herpes Genitalis	Drug: Valacyclovir hydrochloride	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      ViRx Inc, San Francisco,  California,  94109,  United States
      Kraus Med Partners, Los Angeles,  California,  90036,  United States
      Pacific Oaks Research, Beverly Hills,  California,  90211,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States
      IDC Research Initiative, Altamonte Springs,  Florida,  32701,  United States
      Palm Beach Research Ctr, West Palm Beach,  Florida,  33409,  United States
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States
      Healthnet Institute, Fort Lauderdale,  Florida,  33316,  United States
Indiana
      Indiana Univ School of Medicine / Dept of Infect Dis, Indianapolis,  Indiana,  46202,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States
New Jersey
      Advanced Biomedical Research Inc, Hackensack,  New Jersey,  07601,  United States
North Carolina
      Wake County Dept of Health, Raleigh,  North Carolina,  27610,  United States
      Nalle Clinic / Clinical Research Dept, Charlotte,  North Carolina,  28207,  United States
Oregon
      Westover Heights Clinic, Portland,  Oregon,  97210,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
Rhode Island
      Dr Alvan Fisher, Providence,  Rhode Island,  02907,  United States
Texas
      Baylor College of Medicine / Dept of Medicine, Houston,  Texas,  770303498,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23219,  United States
Washington
      Univ of Washington Virology Research Clinic, Seattle,  Washington,  98122,  United States
Canada, Alberta
      Dr Barbara Romanowski, Edmonton,  Alberta,  Canada
Canada, Ontario
      Sunnybrook Health Science Ctr, Toronto,  Ontario,  Canada
Canada, Quebec
      Clinique Medicale L'Actuele, Montreal,  Quebec,  Canada
      Centre De Recherche En Infectiologie, Ste Foy,  Quebec,  Canada

Study ID Numbers:  104C; HS230018
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  May 11, 2000
ClinicalTrials.gov Identifier:  NCT00005663
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08