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Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons (ACV-VAL)

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: NCT01026454
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : March 5, 2014
Last Update Posted : April 8, 2014
Information provided by (Responsible Party):
Connie Celum, University of Washington

Brief Summary:
The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.

Condition or disease Intervention/treatment Phase
HSV Infection HIV Infection Drug: acyclovir Drug: valacyclovir Phase 4

Detailed Description:
Sexual transmission is responsible for the vast majority of HIV-1 infections among adults worldwide. In sub-Saharan Africa, the region hardest hit by the HIV-1 epidemic, HSV-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with HIV-1. HSV-2 is common in those with, or at risk for, HIV-1 infection, and HSV-2 reactivation increases HIV-1 acquisition and infectiousness. Recent studies have shown that suppression of HSV-2 has a sustained effect on lowering HIV-1 levels in blood plasma. New data have raised the question whether higher doses of HSV-2 suppressive therapy might be more effective at suppressing HIV-1 levels. Acyclovir and valacyclovir, chosen for use in this study, are safe and effective treatments for decreasing the frequency of HSV-2 reactivation and shedding. The standard dose of acyclovir is 400 mg twice a day. Valacyclovir, a drug that converts to acyclovir after absorption, delivers higher concentrations of acyclovir. 1.5 grams of valacyclovir, will be used to provide a higher dose of acyclovir, and will be compared with the standard dose of 400 mg twice a day of acyclovir.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Crossover Trial of the Effect of High-dose Daily HSV-2 Suppressive Therapy on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
Study Start Date : February 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: acyclovir
acyclovir 400 mg orally twice daily
Drug: acyclovir
acyclovir 400 mg orally, twice daily for 12 weeks

Active Comparator: valacyclovir
valacyclovir 1.5 g orally twice daily
Drug: valacyclovir
valacyclovir 1.5 g orally, twice daily, for 12 weeks

Primary Outcome Measures :
  1. Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir. [ Time Frame: Weekly for 12 weeks per intervention ]
    Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.

Secondary Outcome Measures :
  1. Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons. [ Time Frame: 28 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:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-1 seropositive
  • Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
  • CD4 cell count >250 cell/µL
  • Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines
  • Detectable HIV-1 plasma viral load
  • HSV-2 seropositive
  • Not intending to move out of the area for the duration of study participation.
  • Able to participate in the study at the Partners in Prevention site in Thika, Kenya

Exclusion Criteria:

  • Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
  • Planned use of acyclovir, valacyclovir, or famciclovir
  • Use of ganciclovir, foscarnet, or cidofovir
  • Known medical history of seizures
  • Serum creatinine >1.5 mg/dL
  • AST or ALT >3 times upper limit of normal
  • Hematocrit <30 %
  • Absolute neutrophil count <1000
  • Platelet count <75,000
  • History of thrombotic microangiopathy
  • Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
  • Participation in another HIV therapeutics trial
  • For women, pregnancy as confirmed by a urine pregnancy test

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): NCT01026454

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Thika Partners in Prevention
Thika, Kenya
Sponsors and Collaborators
University of Washington
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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, US Principal Investigator, University of Washington Identifier: NCT01026454    
Other Study ID Numbers: 37162-A
First Posted: December 4, 2009    Key Record Dates
Results First Posted: March 5, 2014
Last Update Posted: April 8, 2014
Last Verified: March 2014
Keywords provided by Connie Celum, University of Washington:
Additional relevant MeSH terms:
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Communicable Diseases
Antiviral Agents
Anti-Infective Agents