Herpes SimplexPhase 3NCT00005663
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
A Phase 3 study testing Valacyclovir hydrochloride in people with Herpes Simplex and HIV Infections, run by Glaxo Wellcome at 24 sites in 2 countries.
Trial summary
The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex, HIV Infections, Herpes Genitalis
- What is being tested?
- Valacyclovir hydrochloride
- How many people
- Not given
- Where
- 24 sitesin 2 countries
- Study dates
- Jun 1999to not given
- Phase
- Phase 3
- 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 may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Have herpes simplex virus (HSV) 2.
- Have received combination anti-HIV therapy for at least 2 months before entering the study.
- Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
- Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.)
Who cannot join
- Patients will not be eligible for this study if they:
- Have blood vessel disease.
- Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
- Are unable to take medications by mouth.
- Have non-healed sores on the anus or genitals at beginning of study.
- Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
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- Are using interferon. Patients receiving interferon must stop interferon before beginning the study.
- Have kidney or liver problems.
- Are pregnant or breast-feeding.
- Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States20 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
East Bay AIDS Ctr
Berkeley, California, 94705
Pacific Oaks Research
Beverly Hills, California, 90211
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
Healthnet Institute
Fort Lauderdale, Florida, 33316
Advanced Biomedical Research Inc
Hackensack, New Jersey, 07601
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, 46202
Kraus Med Partners
Los Angeles, California, 90036
Univ of Miami School of Medicine
Miami, Florida, 331361013
Univ of Minnesota
Minneapolis, Minnesota, 55455
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Westover Heights Clinic
Portland, Oregon, 97210
Dr Alvan Fisher
Providence, Rhode Island, 02907
Wake County Dept of Health
Raleigh, North Carolina, 27610
Richmond AIDS Consortium
Richmond, Virginia, 23219
ViRx Inc
San Francisco, California, 94109
Univ of Washington Virology Research Clinic
Seattle, Washington, 98122
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Palm Beach Research Ctr
West Palm Beach, Florida, 33409
Canada4 sites
Dr Barbara Romanowski
Edmonton, Alberta
Clinique Medicale L'Actuele
Montreal, Quebec
Centre De Recherche En Infectiologie
Ste Foy, Quebec
Sunnybrook Health Science Ctr
Toronto, Ontario
About this study
Official title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
Read the detailed description
Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.
- Conditions
- Herpes Simplex, HIV Infections, Herpes Genitalis
- Being tested
- Valacyclovir hydrochloride
- Keywords
- Herpes Simplex, Antiviral Agents, Anus Diseases, Herpes Genitalis, Recurrence, valacyclovir
- Medical subject headings
- Herpes Simplex, HIV Infections, Herpes Genitalis, Anus Diseases, 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)
- Study startJun 1999
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 3
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005663
- Sponsor's protocol ID
- 104C
- Other IDs
- HS230018
- Status last verified
- Jul 2001
- First submitted
- 11 May 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00005663
- Acronym / sponsor ID
- 104C
- Conditions
- Herpes Simplex, HIV Infections, Herpes Genitalis
- Keywords
- Herpes Simplex, Antiviral Agents, Anus Diseases, Herpes Genitalis, Recurrence, valacyclovir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- 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 (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
Detailed description
Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.
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 (7 listed)
- Are at least 18 years old.
- Are HIV-positive.
- Have herpes simplex virus (HSV) 2.
- Have received combination anti-HIV therapy for at least 2 months before entering the study.
- Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
Key exclusion criteria (10 listed)
- Have blood vessel disease.
- Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
- Are unable to take medications by mouth.
- Have non-healed sores on the anus or genitals at beginning of study.
- Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valacyclovir hydrochloride in people with Herpes Simplex and HIV Infections, run by Glaxo Wellcome at 24 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 24 Jun 2005.