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

December 4, 2012 updated by: Anna Wald, University of Washington
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37304-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Valacyclovir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe