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Brief Title † | A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients |
Official Title † | A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients |
Brief Summary | To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100). |
Detailed Description | Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy. |
Study Phase | |
Study Type † | Interventional |
Study Design † | Treatment, Safety Study |
Primary Outcome Measure † | |
Secondary Outcome Measure † | |
Condition † | Herpes Simplex HIV Infections |
Intervention † | Drug: Valacyclovir hydrochloride Drug: Acyclovir |
MEDLINE PMIDs | |
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Recruitment Information Fields | |
Recruitment Status † | Completed |
Enrollment † | |
Start Date † | |
Completion Date | |
Eligibility Criteria † | Inclusion Criteria Patients must have the following:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
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Gender | Both |
Ages | 13 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Administrative Information Fields | |
NCT ID † | NCT00002000 |
Organization ID | 104A |
Secondary IDs †† | 08 |
Study Sponsor † | Glaxo Wellcome |
Collaborators †† | |
Investigators † | |
Information Provided By | NIH AIDS Clinical Trials Information Service |
Verification Date | April 1996 |
First Received Date † | November 2, 1999 |
Last Updated Date | June 23, 2005 |