An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
Primary Purpose
HIV, HIV Infections
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valacyclovir
Sponsored by
About this trial
This is an interventional basic science trial for HIV focused on measuring HIV, Valacyclovir, Valtrex®
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment.
Secondary Outcome Measures
To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir
Full Information
NCT ID
NCT01059084
First Posted
January 27, 2010
Last Updated
December 4, 2012
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT01059084
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
We were unable to enroll any participants into this study.
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV, Valacyclovir, Valtrex®
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Intervention Description
1000 mg tid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir
Time Frame
Weeks 7 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Wald, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
We'll reach out to this number within 24 hrs