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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HSV Infection HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acyclovir

acyclovir 400 mg orally twice daily

Group Type ACTIVE_COMPARATOR

acyclovir

Intervention Type DRUG

acyclovir 400 mg orally, twice daily for 12 weeks

valacyclovir

valacyclovir 1.5 g orally twice daily

Group Type ACTIVE_COMPARATOR

valacyclovir

Intervention Type DRUG

valacyclovir 1.5 g orally, twice daily, for 12 weeks

Interventions

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acyclovir

acyclovir 400 mg orally, twice daily for 12 weeks

Intervention Type DRUG

valacyclovir

valacyclovir 1.5 g orally, twice daily, for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No