A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); National Institute on Drug Abuse (NIDA)
• Treatments: Acyclovir

Criteria

Inclusion Criteria For All Participants:

• HIV-uninfected

• HSV-2 infected

• Plans to stay in the area for the duration of study participation

• Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information

Inclusion Criteria for MSM:

• At least 1 episode of anal intercourse with another man within 6 months of study entry

Inclusion Criteria for WSM:

• At least 1 episode of unprotected vaginal sex within 6 months of study entry

Exclusion Criteria For All Participants:

• Current enrollment in another HIV vaccine or prevention trial

• History of adverse reaction to acyclovir

• Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.

• Known plans for travel away from study site for more than 2 months

Exclusion Criteria for MSM:

• In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years

• Reported sex at birth as female

Exclusion Criteria for WSM:

• Pregnancy at screening or enrollment