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

Phase 3

Completed

• Conditions: HIV Infections; Herpes Simplex; Sexually Transmitted Diseases
• Interventions: Drug: Valacyclovir; Drug: Matching Placebo

• Registration Number: NCT00465205
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-12
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-23
• Study First Posted: 2007-04-24
• Study Completion: 2007-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I	Matching Placebo	-
I	Valacyclovir	-

Primary Outcome Measures

Name	Time	Method
Plasma HIV-1 levels and HIV-1 mucosal shedding	18 weeks

Secondary Outcome Measures

Name	Time	Method
Mucosal HSV-2 shedding	18 weeks
Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;	18 weeks

Trial Locations

Locations (1)

Asociacion Civil Impacta Salud y Educacion; 🇵🇪 Lima, Peru