Herpes SimplexNCT00002404
The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
A study testing Valacyclovir hydrochloride in people with Herpes Simplex and HIV Infections, run by Glaxo Wellcome.
Trial summary
The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex, HIV Infections
- What is being tested?
- Valacyclovir hydrochloride
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Patients must have:
- Serologically documented HSV-2 and HIV-1 infection.
- History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
- No contraindications to valacyclovir.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Hepatic impairment.
- Impaired renal function (creatinine above 2 mg/dl).
- Malabsorption syndrome or other gastrointestinal dysfunction.
- Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.
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- Patients with the following prior conditions are excluded:
- History of hypersensitivity to acyclovir or valacyclovir.
- Prior Medication:
- Excluded:
- Participation in any investigational drug trial within 1 month prior to entry on study.
- Systemic anti-HSV therapy within 7 days prior to start of study drug.
- 1. Probenecid.
- Suppressive treatment with medication that has anti-HSV activity.
- Required:
- Stable antiretroviral therapy or no therapy for at least 1 month.
About this study
Official title: The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study
The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.
Read the detailed description
Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.
All patients are treated for 10 days.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Valacyclovir hydrochloride
- Keywords
- HIV-1, Antiviral Agents, Herpes Genitalis, Recurrence, DNA, Viral, RNA, Viral, valacyclovir, Herpesvirus 2, Human
- Medical subject headings
- Herpes Simplex, HIV Infections, Herpes Genitalis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002404
- Sponsor's protocol ID
- 291A
- Status last verified
- Jun 1999
- First submitted
- 2 Nov 1999
- Last updated
- 29 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study
- ClinicalTrials.gov ID
- NCT00002404
- Acronym / sponsor ID
- 291A
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- HIV-1, Antiviral Agents, Herpes Genitalis, Recurrence, DNA, Viral, RNA, Viral, valacyclovir, Herpesvirus 2, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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 see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.
Detailed description
Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.
All patients are treated for 10 days.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Serologically documented HSV-2 and HIV-1 infection.
- History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
- No contraindications to valacyclovir.
Key exclusion criteria (16 listed)
- Hepatic impairment.
- Impaired renal function (creatinine above 2 mg/dl).
- Malabsorption syndrome or other gastrointestinal dysfunction.
- Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.
- History of hypersensitivity to acyclovir or valacyclovir.
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 |
|---|---|---|
| Valacyclovir hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir hydrochloride in people with Herpes Simplex and HIV Infections, run by Glaxo Wellcome.
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 4 inclusion and 16 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 29 Jan 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 29 Jan 2008.