HIVNCT01059084
An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
A study testing Valacyclovir in people with HIV and HIV Infections, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Valacyclovir
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
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- 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
Who cannot join
- 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
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- 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
About this study
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.
Read the 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.
- Conditions
- HIV, HIV Infections
- Being tested
- Valacyclovir
- Keywords
- HIV, Valacyclovir, Valtrex®
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
1000 mg tid
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment.
Measured: Weeks (1-10)
Secondary outcomes (1)
To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir
Measured: Weeks 7 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: We were unable to enroll any participants into this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Wald, University of Washington
- Investigators
- Anna Wald, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059084
- Sponsor's protocol ID
- 37304-B
- Status last verified
- Dec 2012
- First submitted
- 27 Jan 2010
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01059084
- Acronym / sponsor ID
- 37304-B
- Conditions
- HIV, HIV Infections
- Keywords
- HIV, Valacyclovir, Valtrex®
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to enroll any participants into this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- > 18 years old
- HIV-1 seropositive
- CD4 count>250 cell/mm3
- Detectable HIV-1 plasma viral load
- HSV-1 \& 2 seronegative.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valacyclovir1000 mg tid | Drug | – |
Primary outcome
To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment.
Time frame: Weeks (1-10)
1 secondary outcome
To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir
Time frame: Weeks 7 and 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Wald, MD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir in people with HIV and HIV Infections, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment. (time frame: Weeks (1-10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.