Ancillary Study: Prospective Cohort Study of HPTN 039 Seroconverters: The Effect of HSV-2 Suppression on HIV-1 Viral Set Point
Protocol Status: Concluded
Study Purpose: To determine the effect of HSV-2 suppression with twice-daily acyclovir during the first six months after HIV acquisition on HIV viral set point.
Study Design: Prospective multi-site cohort study.
Study Population: Women and men who have sex with men (WSM, MSM) enrolled in the randomized-controlled trial of acyclovir in the reduction of HIV acquisition (HPTN 039) who are identified as HIV-positive during follow-up.
Study Size: Estimated 81 seroconverters: 54 on placebo, 27 on acyclovir.
Study Duration: Participants who seroconvert will be followed for six months after enrollment; participants who seroconvert will be enrolled within 60 days of when the first HIV positive sample was collected for HPTN 039.
Treatment Regimen: Acyclovir 400 mg po bid or matching placebo po bid (continuation of HPTN 039 treatment).
Primary Objectives: To measure the efficacy of twice daily acycovir suppressive therapy on HIV plasma viral RNA levels during the first six months after determination of HIV infection.
Secondary Objectives: 1) To assess the effect of acyclovir suppressive therapy on CD4 counts over the first six months after infection. 2) To describe the incidence and severity of clinical HSV reactivation, as detected during visits or reported by participants, during early HIV infection.