None listed
Conditions
Interventions
Group 1 Type of group
2 weeks of treatment with Valacyclovir 500 mg orally twice a day followed by a pharmacological rest period of 2 weeks without treatment and then 12 weeks of placebo, one pill orally twice a day.
Group name:Group 2 Type of group
12 weeks of placebo treatment one pill twice a day followed by a pharmacological rest period of 2 weeks without treatment, and then 12 weeks of Valacyclovir 500 mg orally twice a day.
Sponsors
GLAXO WELCOME S.A., UNIVERSIDAD CASE WESTERN RESERVE,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • HIV-1 infection, as documented by an ELISA test kit licensed and confirmed by the Western Blot test at any time before study entry. Culture of HIV-1, HIV-1 antigen, HIV-1 RNA in plasma, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. • No antiretroviral therapy for at least 6 months, and it is not likely to start within the next 6 months. • CD4 + cell count> = 500 cells / mm3 obtained within 30 days before entering the study in any laboratory that has a CLIA certification or its equivalent. • HSV-2 negative selection serology. Candidates for the study will be selected on the basis of having negative HSV-2 seroestatus, but confirmation of their status must be confirmed at the selection visit. • VlH-1 RNA> = 1,000 copies / mL obtained within 30 days before entering the study by any laboratory that has a CLIA certification or its equivalent. • Laboratory values ​​obtained within 120 days before admission as shown below: Absolute neutrophil count (ANC)> 1000 / mm3, Hemoglobin> 10.0 g / dL, Platelet count S 50,000 / mm3, AST (SGOT ), ALT (SGPT). and alkaline phosphatase 70 within 30 days before admission. • Age of men and women> 18 years. • Ability or willingness of the participant or legal guardian / representative to provide informed consent.
Exclusion criteria
Exclusion criteria: • Breastfeeding • Continuous use of the following medications for more than 3 days within 30 days of entering the study: Immunosuppressants, immunomodulators, systemic glucocorticoids, antineoplastic agents • Active drug or alcohol abuse or dependence that, in the opinion of the site researcher, would interfere with compliance with the study requirements. • Serious illness that requires systemic treatment and / or hospitalization within 30 days before admission. • Renal impairment (serum creatinine> 2.0 mg / L or urine protein> 500mg / L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The selection of VlH-1 RNA must be carried out within 120 days before entering the study using any FDA-approved method of HIV-1 RNA by a laboratory that has CLIA certification or its equivalent. Eligibility will be determined based on the selection value. Measure:Changes in plasma levels of HIV-RNA Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:No Information Measure:No Information Timepoints:No Information | — |
Contacts
Public ContactSara Rocio de los Milagros Tume
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed