Herpes SimplexNCT00002084
A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
A study testing Valacyclovir hydrochloride and Acyclovir in people with Herpes Simplex and HIV Infections, run by Glaxo Wellcome at 46 sites in United States.
Trial summary
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3. 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 and Acyclovir
- How many people
- Not given
- Where
- 46 sitesUnited States
- 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:
- HIV infection with CD4 counts = or > 100 cells/mm3.
- Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
- History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.
- Concurrent Medication:
- Excluded:
- Systemic antiherpes medication.
Show all 9Show fewer
- Interferon.
- Patients with the following prior conditions are excluded:
- History of hypersensitivity to acyclovir.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Emory Univ School of Medicine
Atlanta, Georgia, 30303
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Univ of Maryland at Baltimore
Baltimore, Maryland, 21201
Northwestern Memorial Hosp
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Dallas Associated Dermatologists
Dallas, Texas, 75246
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Thomas Audetta Clinic
Houston, Texas, 77006
Baylor College of Medicine / Texas Med Ctr
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas, 77030
MacGregor Med Association
Houston, Texas, 77054
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Iowa Hosp & Clinic
Iowa City, Iowa, 52242
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39216
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Combat Group
Los Angeles, California, 90028
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
Univ of South Alabama
Mobile, Alabama, 36604
Univ TX Med Branch / Ctr for Clinical Studies
Nassau Bay, Texas, 77058
Beth Israel Med Ctr
New York, New York, 10003
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
Mount Sinai Med Ctr
New York, New York, 10029
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, 94609
UCI Med Ctr
Orange, California, 92668
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, 15261
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Roger Williams Med Ctr
Providence, Rhode Island, 02908
Med College of Virginia
Richmond, Virginia, 232980049
Univ of Rochester Med Ctr
Rochester, New York, 14642
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101
UCSD Med Ctr
San Diego, California, 92103
San Diego Naval Hosp
San Diego, California, 921345000
ViRx Inc
San Francisco, California, 94103
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Dr Marcus Conant
San Francisco, California, 94115
St Louis Univ
St Louis, Missouri, 63104
Univ of South Florida
St. Petersburg, Florida, 33705
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
West Haven Veterans Administration Med Ctr
West Haven, Connecticut, 06516
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
About this study
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.
- Conditions
- Herpes Simplex, HIV Infections
- Being tested
- Valacyclovir hydrochloride, Acyclovir
- Keywords
- Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Anus Diseases, Herpes Genitalis
- Medical subject headings
- Herpes Simplex, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Anus Diseases, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir hydrochlorideDrug
AcyclovirDrug
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
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002084
- Sponsor's protocol ID
- 104B
- Other IDs
- 07
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- 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
- A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002084
- Acronym / sponsor ID
- 104B
- Conditions
- Herpes Simplex, HIV Infections
- Keywords
- Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Anus Diseases, Herpes Genitalis
- Study type
- Interventional
- Recruitment status
- Completed
- 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.
To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infection with CD4 counts = or > 100 cells/mm3.
- Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
- History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.
Key exclusion criteria (9 listed)
- Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.
- Systemic antiherpes medication.
- Interferon.
- History of hypersensitivity to acyclovir.
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 | – |
| Acyclovir | 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 24 Jun 2005.
Related trials for Herpes Simplex
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection
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.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir hydrochloride and Acyclovir in people with Herpes Simplex and HIV Infections, run by Glaxo Wellcome at 46 sites 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 4 inclusion and 9 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 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 46 sites 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. 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 24 Jun 2005.