HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.

The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.

This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

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

Details

• Lead Sponsor: University of Washington
• Collaborators: Asociación Civil Impacta Salud y Educación, Peru; GlaxoSmithKline
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• Greater than 18 years old woman,

• Documented HIV-1 seropositive,

• CD4 count greater than 200,

• Not on HIV antiretroviral therapy,

• HSV-2 seropositive as determined by Focus EIA (IN >3.5)

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

• Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.

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

Exclusion Criteria:

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

• Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;

• Planned open label use of acyclovir, valacyclovir, or famciclovir

• Known medical history of seizures

• Known renal failure, serum creatinine >2.0mg/dl

• Hematocrit < 30 %