None listed
Conditions
Interventions
Valanciclovir Type of group
You will be given 500 mg of valanciclovir.
Group name:Placebo Type of group
Se administrara placebo de valanciclovir.
Sponsors
GLAXOSMITHKLINE RESEARCH TRIANGLE PARK,
Eligibility
Inclusion criteria
Inclusion criteria: • Be over 18 years of age. • Be documented HIV-1 positive. • Have a CD4 count greater than 200. • Not receiving antiretroviral therapy for HIV. • Be positive VHS-2 determined by the EIA test (IN> 3.5). • Do not intend to travel or emigrate during the time the study lasts.
Exclusion criteria
Exclusion criteria: ■ Known history of adverse reactions to valacyclovir, aciclovir or famciciovir. ■ Plan the open use of Aciclovir, valaciclovir, or famciciovir. ■ History of seizures. ■ Renal insufficiency or serum creatinine> 2.0 mg / dl. ■ Hematocrit less than 30%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Average HIV RNA in rectal secretion and seminal plasma in MSM or rectal and cervical secretions in women at the end of the phase with valaciclovir versus placebo phase. Measure:Average HIV RNA in rectal secretion and seminal plasma in MSM or rectal and cervical secretions in women at the end of the phase with valaciclovir versus placebo phase. Timepoints:biweekly | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Excretion of HIV in the rectum, pharynx and semen. Measure:To determine the temporal pattern of excretion of HIV in the rectum, pharynx and semen with respect to episodes of reactivation of HSV 1 and HSV 2 in mucous membranes. Timepoints:biweekly | — |
Countries
Peru, United States
Outcome results
None listed