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

NCT ID: NCT00465205

Last Updated: 2013-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-12-31

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.

Conditions

HIV Infections; Herpes Simplex; Sexually Transmitted Diseases

Keywords

HIV infection; HIV Shedding; HSV suppression; Co-infected; Women; Reactivation; Valacyclovir; Treatment Naive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

I

Group Type: EXPERIMENTAL

Valacyclovir

Intervention Type: DRUG

500mg oral twice daily

Matching Placebo

Intervention Type: DRUG

500 mg oral twice daily

Interventions

Valacyclovir

500mg oral twice daily

Intervention Type: DRUG

Matching Placebo

500 mg oral twice daily

Intervention Type: DRUG

Other Intervention Names

Valtrex; Placebo for Valacyclovir

Eligibility 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 %

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Asociación Civil Impacta Salud y Educación, Peru

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Connie Celum, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Asociacion Civil Impacta Salud y Educacion

Lima, , Peru

Countries

Peru

References

Baeten JM, Strick LB, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Magaret A, Wald A, Corey L, Celum C. Herpes simplex virus (HSV)-suppressive therapy decreases plasma and genital HIV-1 levels in HSV-2/HIV-1 coinfected women: a randomized, placebo-controlled, cross-over trial. J Infect Dis. 2008 Dec 15;198(12):1804-8. doi: 10.1086/593214.

Reference Type: DERIVED

PMID: 18928378 (View on PubMed)

Other Identifiers

AI277S7;AI38858;AI30731

Identifier Type: -

Identifier Source: secondary_id

21760-A (2)

Identifier Type: -

Identifier Source: org_study_id