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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465205
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : August 22, 2013
Asociación Civil Impacta Salud y Educación, Peru
Information provided by:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: I Drug: Valacyclovir
500mg oral twice daily
Other Name: Valtrex

Drug: Matching Placebo
500 mg oral twice daily
Other Name: Placebo for Valacyclovir

Primary Outcome Measures :
  1. Plasma HIV-1 levels and HIV-1 mucosal shedding [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Mucosal HSV-2 shedding [ Time Frame: 18 weeks ]
  2. Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation; [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 %

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465205

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Asociacion Civil Impacta Salud y Educacion
Lima, Peru
Sponsors and Collaborators
University of Washington
Asociación Civil Impacta Salud y Educación, Peru
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Principal Investigator: Connie Celum, MD, MPH University of Washington
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Connie Celum MD MPH, University of Washington Identifier: NCT00465205    
Other Study ID Numbers: 21760-A (2)
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013
Keywords provided by University of Washington:
HIV infection
HIV Shedding
HSV suppression
Treatment Naive
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
HIV Infections
Herpes Simplex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents