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Clinical Trials

MainTitle

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
University of Washington


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
History of Changes
Purpose

Purpose

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 Intervention Phase
HSV Infection
HIV Infection

Drug : acyclovir
Drug : valacyclovir
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Connie Celum, University of Washington:

Primary Outcome Measures

  • 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:
  • Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons. [ Time Frame: 28 weeks ]

Enrollment: 32
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026454

Locations

Kenya
Thika Partners in Prevention
Thika, Kenya

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator: Connie Celum, MD, MPH University of Washington
More Information

More Information


Responsible Party: Connie Celum, US Principal Investigator, University of Washington  
ClinicalTrials.gov Identifier: NCT01026454   History of Changes  
Other Study ID Numbers: 37162-A  
Study First Received: December 2, 2009  
Last Updated: March 10, 2014  

Keywords provided by Connie Celum, University of Washington:

HSV
HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Herpes Simplex
Valacyclovir
Acyclovir

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.