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

HIV Infections Clinical Trial

Official title:

A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-infected Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465205
• Other study ID #: 21760-A (2)
• Secondary ID: AI277S7;AI38858
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2007
• Last updated: August 21, 2013
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Simplex
• HIV Infections
• Sexually Transmitted Diseases

Intervention

Drug:
• Valacyclovir
500mg oral twice daily
• Matching Placebo
500 mg oral twice daily

Locations

Country	Name	City	State
Peru	Asociacion Civil Impacta Salud y Educacion	Lima

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Asociación Civil Impacta Salud y Educación, Peru, GlaxoSmithKline

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma HIV-1 levels and HIV-1 mucosal shedding		18 weeks	No
Secondary	Mucosal HSV-2 shedding		18 weeks	No
Secondary	Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;		18 weeks	No