Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: Institute for the Development of Africa
• Treatments: Acyclovir

Criteria

Inclusion Criteria:

• 18 years old and above

• Documented HIV-seropositive

• HSV-2 seropositive as determined by Focus EIA

• Not intending to move out of the area for the duration of study participation

• Willing and able to:

1. provide independent written informed consent

2. undergo clinical evaluations

3. take study drug as directed

4. adhere to follow-up schedule

• Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea, chlamydia, syphilis) are treated within two weeks if study enrollment and random assignment.

Exclusion Criteria:

• Women who meet any of the following criteria are not eligible for this study.

1. Known history of adverse reaction to acyclovir

2. Planned open label use of acyclovir, valacyclovir, or famciclovir

3. Positive pregnancy test

4. Active opportunistic infection