Phase 4 N=32 Randomized Treatment

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

HSV Infection · HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT01026454 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir. — 3.56; 2.94 log10 copies/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: acyclovir (Drug); valacyclovir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.	3.56; 2.94	—
SECONDARY Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01026454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.