The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.
Women coinfected with HIV and HSV-2 experience more genital herpes outbreaks than women infected only with HSV-2. Frequent or recurrent herpes outbreaks in women infected with HIV can lead to an increase in both HIV plasma viral load and cervical shedding of HIV. Some preliminary clinical studies have shown that acyclovir treatment for the management of HSV-2 infection can help lower HIV viral load in patients coinfected with both HIV and HSV-2. Supplementing highly active antiretroviral therapy (HAART) with HSV-2 treatment in patients coinfected with both HIV and HSV-2 may help strengthen the effects of HAART by more effectively lowering plasma and genital HIV viral load. This study will determine whether HSV-2 treatment with acyclovir is effective in controlling HIV plasma viral load and cervical shedding of HIV in women starting on HAART as per Peruvian guidelines. This study will last 24 weeks. Participants will be randomly assigned into one of two groups. Group 1 participants will receive twice-daily 800 mg of acyclovir for 24 weeks. Group 2 participants will receive twice-daily placebo for 24 weeks. Both groups will receive HAART from the Peruvian Ministry of Health. There will be 15 visits during this study. Medical history; a physical exam; blood collection; family planning counseling; and cervical, vaginal, and vulvar swab collection will begin prior to study entry and will occur at all study visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
800 mg tablet taken orally twice daily
800 mg placebo tablet taken orally twice daily
IMPACTA - San Miguel CIPRA Project 1 CRS
San Miguel, Lima region, Peru
Undetectable HIV plasma RNA viral load (less than 50 copies/ml)
Time frame: At Week 6
Undetectable HIV plasma RNA viral load (less than 50 copies/ml)
Time frame: At Week 24
Time to undetectable HIV plasma RNA viral load (less than 50 copies/ml), adjusted for baseline viral load
Time frame: Throughout study
Intermittent episodes of detectable HIV plasma RNA viral load (greater than 200 copies/ml)
Time frame: At Weeks 2 and 24
Positive HIV PCR test on vaginal mucosal samples
Time frame: Throughout study
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