This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.

Condition	Treatment or Intervention	Phase
Herpes Genitalis HIV Infections	Drug: Investigational Genital Herpes Drug	Phase IV

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

Criteria

Inclusion Criteria:

• CD4+ lymphocyte count <100cells/mm3 at the screening visit.
• Documented history of HIV infections
• Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study.
• Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test).
• 3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
• 3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.

Exclusion Criteria:

• Kidney diseases.
• Liver diseases.
• Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
• Vomiting syndrome.
• Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation.
• Active AIDS-indicator conditions, as defined by CDC Category C.
• Other protocol inclusion and exclusion criteria to be evaluated by the research physician.

California
      Beverly Hills,  California,  90211,  United States
Colorado
      Denver,  Colorado,  80104,  United States
Florida
      Altamonte Springs,  Florida,  32701,  United States
      Fort Myers,  Florida,  33901,  United States
Illinois
      Chicago,  Illinois,  60657,  United States
Massachusetts
      Boston,  Massachusetts,  02115,  United States
Missouri
      St. Louis,  Missouri,  63108,  United States
New Jersey
      Voorhees,  New Jersey,  08043,  United States
Texas
      Dallas,  Texas,  75246,  United States
      Fort Worth,  Texas,  76104,  United States
Washington
      Seattle,  Washington,  98122,  United States

Study ID Numbers:  100181
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  March 18, 2004
ClinicalTrials.gov Identifier:  NCT00079911
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08