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

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University of Washington

Status and phase

Completed
Phase 4

Conditions

HIV Infection
HSV Infection

Treatments

Drug: valacyclovir
Drug: acyclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT01026454
37162-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 2 patient groups

acyclovir
Active Comparator group
Description:
acyclovir 400 mg orally twice daily
Treatment:
Drug: acyclovir
valacyclovir
Active Comparator group
Description:
valacyclovir 1.5 g orally twice daily
Treatment:
Drug: valacyclovir

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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