NCT00371592

Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)

A Phase II, Randomized, Double-blind, Placebo-controlled Trial of Acyclovir for the Suppression of Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load and Mucosal Shedding in HIV-1, Herpes Simplex Virus, Type 2 (HSV-2) Co-Infected Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• Herpesvirus 2, Human

Interventions

Type	Name	Description
DRUG	Acyclovir	800 mg tablet taken orally twice daily
DRUG	Acyclovir placebo	800 mg placebo tablet taken orally twice daily

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-09-04
• Last updated: 2013-09-23

Locations

1 site across 1 country: Peru