We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01059084
Recruitment Status : Withdrawn (We were unable to enroll any participants into this study.)
First Posted : January 29, 2010
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to look at the effect of daily herpes medication, valacyclovir, on HIV levels in the blood in persons who are HIV positive and do not have oral or genital herpes.

Condition or disease Intervention/treatment
HIV HIV Infections Drug: Valacyclovir

Detailed Description:

The purpose of this study is to look at the effect of daily herpes medication, valacyclovir on HIV levels in the blood in persons who do not have genital herpes. This will help better understand the effect that valacyclovir plays in the spread of HIV and the potential role for HIV treatment in decreasing the HIV spread.

A total of 20 individuals who are HIV-1 seropositive and HSV-1/2 seronegative will be recruited for the study. Participants must not be on antiretroviral therapy and must not be planning to initiate HIV antiretroviral therapy during the study.

Participants will be asked to come to the clinic for a total of 16 visits over the course of 10 weeks. Participants will receive valacyclovir 1000 mg three times daily for 6 weeks. During the first week, participants will return to the clinic for a total of 2 visits and will provide plasma samples for baseline HIV-1 levels. During the second week, participants will return to the clinic for a total 5 visits. At Visit 3, participants will be provided the study medication. After drug initiation, participants will be asked to return to the clinic within 6 hours and then again at Day 1, 2, and 3 post first dose. During weeks 3-8, participants will be instructed to take valacyclovir and return to the clinic for one follow-up visit each week to provide plasma samples for HIV-1 detection.

Participants will be asked to return to the clinic for 3 follow-up visits after study drug discontinuation to provide plasma samples for HIV-1 detection.

Participants will be asked to complete a daily symptom and medication diary. All supplies and study medical will be provided.

This is an outpatient study.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
Study Start Date : January 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Valacyclovir
    1000 mg tid

Outcome Measures

Primary Outcome Measures :
  1. To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment. [ Time Frame: Weeks (1-10) ]

Secondary Outcome Measures :
  1. To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir [ Time Frame: Weeks 7 and 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • HIV-1 seropositive
  • CD4 count>250 cell/mm3
  • Detectable HIV-1 plasma viral load
  • HSV-1 & 2 seronegative.
  • Not on HIV antiretroviral therapy or planning to initiate antiretroviral therapy during the study period.
  • Not intending to move out of the area for duration of study participation
  • Willing and able to provide independent written informed consent.
  • Willing and able to undergo clinical evaluations.
  • Willing and able to take study drug as directed.
  • Willing and able to adhere to follow-up schedule

Exclusion Criteria:

  • Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
  • Use of ganciclovir, foscarnet, or cidofovir
  • History of evidence of CMV disease
  • Known medical history of seizures
  • Known renal insufficiency, defined as serum creatine >1.5 mg/dl
  • AST or ALT >3times upper limit of normal
  • Hematocrit <30%
  • Neutropenia, defined as absolute neutrophil count <1000
  • Thrombocytopenia, defined as platelet count <75,000
  • History of thrombotic microangiopathy
  • For women, pregnancy as confirmed by a urine pregnancy test
  • Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059084


Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Anna Wald, MD, MPH University of Washington
More Information

Responsible Party: Anna Wald, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01059084     History of Changes
Other Study ID Numbers: 37304-B
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Anna Wald, University of Washington:
HIV
Valacyclovir
Valtrex®

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents