This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
oral valacyclovir 500mg twice daily
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
Fundación Huesped
Buenos Aires, Argentina
annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time.
Time frame: up to 5 years
time from baseline until reaching the composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first.
Time frame: up to 5 years
Annual rate of change in the CD4 cell count percentage, calculated as the slope of the participants' CD4 count percentage change over time
Time frame: up to 5 years
Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up
Time frame: up to 5 years
Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine)
Time frame: up to 5 years
Frequency of episodes of HSV reactivations at any anatomic site
Time frame: up to 5 years
Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV
Time frame: up to 5 years
Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point
Time frame: up to 5 years
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Instituto de Pesquisa Clínica Evandro Chagas
Rio de Janeiro, Brazil
Ambulatorio de Infectologia da UNIFESP
São Paulo, Brazil
Centro de Referencia e Treinamento em DST/AIDS
São Paulo, Brazil
University of Alberta
Edmonton, Alberta, Canada
B.C. Women's Hospital & Health Centre - Oak Tree Clinic
Vancouver, British Columbia, Canada
Vancouver Infectious Disease Clinic
Vancouver, British Columbia, Canada
Cool Aid Community Health Centre
Victoria, British Columbia, Canada
CDHA, QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
McMaster University Health Sciences Centre
Hamilton, Ontario, Canada
...and 15 more locations