HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-Infected Persons - Full Text View

Sponsor:	University of Washington
Collaborators:	GlaxoSmithKline Asociación Civil Impacta Salud y Educación, Peru
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00465205

Purpose

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.

Condition	Intervention	Phase
HIV Infections Herpes Simplex Sexually Transmitted Diseases	Drug: Valacyclovir Drug: Matching Placebo	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Herpes Simplex Sexually Transmitted Diseases

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mucosal HSV-2 shedding [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I	Drug: Valacyclovir 500mg oral twice daily Other Name: Valtrex Drug: Matching Placebo 500 mg oral twice daily Other Name: Placebo for Valacyclovir

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 %

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465205

Locations

Peru
Asociacion Civil Impacta Salud y Educacion
Lima, Peru

Sponsors and Collaborators

University of Washington

GlaxoSmithKline

Asociación Civil Impacta Salud y Educación, Peru

Investigators

Principal Investigator:

Connie Celum, MD, MPH

University of Washington

More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Connie Celum MD MPH, University of Washington
ClinicalTrials.gov Identifier:	NCT00465205 History of Changes
Other Study ID Numbers:	02-3200-A-05-2, AI277S7;AI38858;AI30731
Study First Received:	April 23, 2007
Last Updated:	March 18, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

HIV infection
HIV Shedding
HSV suppression
Co-infected

Women
Reactivation
Valacyclovir
Treatment Naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Simplex
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections

DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012