HIVNCT00803543
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
A study testing Valacyclovir in people with HIV and HIV Infections, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years or older
- HSV-2 (Herpes simplex virus type 2) seropositive as determined by HerpeSelect-2 ELISA
- Documented HIV-1 seropositive
- Currently receiving HAART for 3 months or longer
- CD4 (cluster of differentiation 4) count 350 or greater
- Women of child bearing potential must agree to use acceptable contraceptive measures during the entire conduct of the study. Acceptable contraceptive methods include one or more of the following: oral hormonal contraceptives, injectable hormonal contraceptives, transdermal hormonal contraceptives, IUD (intrauterine device), diaphragm or cervical cap.
- Willing and able to provide written informed consent, undergo clinical evaluations, and take study drug as directed
Who cannot join
- History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.
- Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
- Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.
- Medical history of seizures
- Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl
- AST (aspartate aminotransferase) or ALT (alanine aminotransferase) over 5 times uper limit of normal
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- History of thrombotic microangiopathy
- For women, pregnancy as confirmed by a urine or serum pregnancy test.
- Any other condition which, in the opinion of the principal investigator, may compromise the subject's ability to follow study procedures and complete the study.
- Participants with active bacterial STDs (sexually transmitted diseases) may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daiy Valacyclovir in the Reduction of HSV-2 Recurrences and Viral Shedding
The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
Read the detailed description
Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes "cold sores" or fever blisters and HSV Type 2 (HSV-2) usually causes lesions in the genital or rectal areas. However, HSV-1 can sometimes cause genital herpes and HSV-2 can cause oral lesions (acquired from oral-genital sex). Herpes Simplex is transmitted by contact with someone who is shedding virus in either the mouth or genital tract, usually by kissing or sexual intercourse. While contact with an active sore can cause transmission, so can contact with saliva or genital secretions that are infected, even when the person does not have an obvious sore. This is called asymptomatic shedding of HSV. Once acquired, the virus has the ability to remain inactive in the nervous system in the area of the mouth or genital region.
Persons with both HIV and HSV-2 often have shedding of both viruses. We know that persons with HSV-2 tend to have increased amounts of HIV in their blood as well. Recently, research studies have found that taking medicine daily to prevent asymptomatic HSV-2 shedding can reduce the amount of HIV found in the blood and in genital secretions. This study seeks to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir (FDA approved drug) reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
- Conditions
- HIV, HIV Infections
- Being tested
- Valacyclovir, Placebo
- Keywords
- HSV-2, Herpes Simplex, HSV Type 2, HIV, HIV/HSV, treatment experienced
- Medical subject headings
- HIV Infections, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Also called There are no other names
500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
PlaceboDrug
Also called There are no other names
Dosage: Two tablets once a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir | Active comparator | This is the arm taking Valacyclovir Receives: Drug: Valacyclovir |
| Placebo | Placebo comparator | This is the arm taking the placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Herpes Simplex Virus Type 2 Recurrence
Number of recurrences of genital herpes
Measured: 24 Weeks
CD4 Count
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Measured: 24 weeks
Number of Participants With an HIV Viral Load of <500 Copies/ml
Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
Measured: 24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding
Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Nicholas Van Wagoner, MD, University of Alabama at Birmingham
- Investigators
- Nicholas Van Wagoner, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803543
- Sponsor's protocol ID
- F080718009
- Status last verified
- Jun 2017
- First submitted
- 3 Dec 2008
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daiy Valacyclovir in the Reduction of HSV-2 Recurrences and Viral Shedding
- ClinicalTrials.gov ID
- NCT00803543
- Acronym / sponsor ID
- F080718009
- Conditions
- HIV, HIV Infections
- Keywords
- HSV-2, Herpes Simplex, HSV Type 2, HIV, HIV/HSV, treatment experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 13 Jul 2017
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 the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
Detailed description
Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes "cold sores" or fever blisters and HSV Type 2 (HSV-2) usually causes lesions in the genital or rectal areas. However, HSV-1 can sometimes cause genital herpes and HSV-2 can cause oral lesions (acquired from oral-genital sex). Herpes Simplex is transmitted by contact with someone who is shedding virus in either the mouth or genital tract, usually by kissing or sexual intercourse. While contact with an active sore can cause transmission, so can contact with saliva or genital secretions that are infected, even when the person does not have an obvious sore. This is called asymptomatic shedding of HSV. Once acquired, the virus has the ability to remain inactive in the nervous system in the area of the mouth or genital region.
Persons with both HIV and HSV-2 often have shedding of both viruses. We know that persons with HSV-2 tend to have increased amounts of HIV in their blood as well. Recently, research studies have found that taking medicine daily to prevent asymptomatic HSV-2 shedding can reduce the amount of HIV found in the blood and in genital secretions. This study seeks to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir (FDA approved drug) reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir | Active comparator | Drug: ValacyclovirThis is the arm taking Valacyclovir |
| Placebo | Placebo comparator | Drug: PlaceboThis is the arm taking the placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 19 years or older
- HSV-2 (Herpes simplex virus type 2) seropositive as determined by HerpeSelect-2 ELISA
- Documented HIV-1 seropositive
- Currently receiving HAART for 3 months or longer
- CD4 (cluster of differentiation 4) count 350 or greater
Key exclusion criteria (10 listed)
- History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.
- Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
- Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.
- Medical history of seizures
- Renal insufficiency, defined as serum creatinine greater than 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 |
|---|---|---|
| ValacyclovirAlso: There are no other names500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks | Drug | Valacyclovir |
| PlaceboAlso: There are no other namesDosage: Two tablets once a day for 24 weeks | Drug | Placebo |
Primary outcome
Herpes Simplex Virus Type 2 Recurrence
Time frame: 24 Weeks
Number of recurrences of genital herpes
CD4 Count
Time frame: 24 weeks
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Number of Participants With an HIV Viral Load of <500 Copies/ml
Time frame: 24 weeks
Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding
Time frame: 24 weeks
Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nicholas Van Wagoner, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
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 Alabama at Birmingham at 1 site in United States.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Herpes Simplex Virus Type 2 Recurrence (time frame: 24 Weeks). The study lists 4 primary outcomes in all. 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 13 Jul 2017.