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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT01026454
First received: December 2, 2009
Last updated: March 10, 2014
Last verified: March 2014

December 2, 2009
March 10, 2014
February 2010
November 2010   (final data collection date for primary outcome measure)
Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir. [ Time Frame: Weekly for 12 weeks per intervention ] [ Designated as safety issue: No ]
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.
Presence and quantity of the 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. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01026454 on ClinicalTrials.gov Archive Site
Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Evaluate the Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HSV Infection
  • HIV Infection
  • Drug: acyclovir
    acyclovir 400 mg orally, twice daily for 12 weeks
  • Drug: valacyclovir
    valacyclovir 1.5 g orally, twice daily, for 12 weeks
  • Active Comparator: acyclovir
    acyclovir 400 mg orally twice daily
    Intervention: Drug: acyclovir
  • Active Comparator: valacyclovir
    valacyclovir 1.5 g orally twice daily
    Intervention: Drug: valacyclovir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01026454
37162-A
No
Connie Celum, University of Washington
University of Washington
Not Provided
Principal Investigator: Connie Celum, MD, MPH University of Washington
University of Washington
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP