HIV InfectionsPhase 3NCT00002315
A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
A Phase 3 study testing Netivudine and Acyclovir in people with HIV Infections and Chickenpox, run by Glaxo Wellcome at 25 sites in United States.
Trial summary
To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Chickenpox
- What is being tested?
- Netivudine and Acyclovir
- How many people
- 400 participants
- Where
- 25 sitesUnited States
- Study dates
- Start not givento 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 must have:
- Acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis.
- Immunocompromised condition primarily as a result of documented HIV infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy.
- Life expectancy of at least 6 months.
- Ability to cooperate with the requirements of the study.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes).
- Acute, life-threatening condition.
- Significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption.
- Intolerance of oral medication.
Show all 23Show fewer
- Concurrent Medication:
- Excluded:
- Tricyclic antidepressants or anti-epileptics.
- Topical applications to the zoster lesions that would obscure evaluation.
- Fluorouracil and flucytosine.
- Systemic therapy with agents with antiherpetic activity (from 2 weeks prior to first dose to day 28 of study).
- Probenecid or other drugs likely to affect elimination of study drugs (from 2 days prior to first dose to day 14 of the study).
- Capsaicin (Zostrix).
- Warfarin (Coumadin) during 14 days of treatment.
- Patients with the following prior conditions are excluded:
- History of intolerance, hypersensitivity, or severe drug reaction to acyclovir.
- Prior Medication:
- Excluded:
- Systemic therapy with agents with antiherpetic activity (including interferon) within the past 2 weeks.
- Probenecid or other drugs likely to affect the elimination of 882C87 or acyclovir within the past 48 hours.
- Drugs likely to interact with 882C87 (e.g., fluorouracil or flucytosine) within the past 7 days.
- Zoster immune globulin or zoster immune plasma within the previous month. History of alcohol or drug abuse within the previous 6 months or current methadone therapy.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
New Mexico Med Group
Albuquerque, New Mexico, 87110
Simon - Williamson Clinic
Birmingham, Alabama, 35211
SORRA / NC Research Ctr
Birmingham, Alabama, 35234
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
Med Associates Clinic
Dubuque, Iowa, 52001
Oregon Research Group
Eugene, Oregon, 97401
Jordon Diagnostics and Research Inc
High Point, North Carolina, 27262
MacGregor Med Association
Houston, Texas, 77054
Cedars Sinai Med Ctr
Los Angeles, California, 90048
Med Consultants LTD
Milwaukee, Wisconsin, 53215
Vanderbilt Med Ctr
Nashville, Tennessee, 37232
Univ TX Med Branch
Nassau Bay, Texas, 77058
Oschner Clinic
New Orleans, Louisiana, 70121
Oregon Health Sciences Univ
Portland, Oregon, 97201
Roger Williams Med Ctr
Providence, Rhode Island, 02908
Silver Lake Med Inc
Providence, Rhode Island, 02909
AIDS Community Research Consortium
Redwood City, California, 94063
Rhinelander Med Ctr
Rhinelander, Wisconsin, 54501
Saint Francis Mem Hosp
San Francisco, California, 94109
Washington Univ
St Louis, Missouri, 63110
Sunnyvale Med Clinic
Sunnyvale, California, 94086
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
Clinical Research Consultants
Trumbull, Connecticut, 06611
Univ of Arizona / Univ Med Ctr
Tucson, Arizona, 85724
Hanover Med Specialists
Wilmington, North Carolina, 28401
About this study
Official title: A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients
To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients.
Read the detailed description
Patients are randomized to receive either 882C87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. They are stratified by presence or absence of HIV infection. Patients undergo 6 months of follow-up.
- Conditions
- HIV Infections, Chickenpox
- Being tested
- Netivudine, Acyclovir
- Keywords
- Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, Chickenpox, Herpes Zoster, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetivudineDrug
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 HIV InfectionsStudies 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
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002315
- Sponsor's protocol ID
- 130A
- Status last verified
- May 1994
- 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 Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT00002315
- Acronym / sponsor ID
- 130A
- Conditions
- HIV Infections, Chickenpox
- Keywords
- Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 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.
To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients.
Detailed description
Patients are randomized to receive either 882C87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. They are stratified by presence or absence of HIV infection. Patients undergo 6 months of follow-up.
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 (5 listed)
- Acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis.
- Immunocompromised condition primarily as a result of documented HIV infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy.
- Life expectancy of at least 6 months.
- Ability to cooperate with the requirements of the study.
Key exclusion criteria (23 listed)
- Evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes).
- Acute, life-threatening condition.
- Significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption.
- Intolerance of oral medication.
- Tricyclic antidepressants or anti-epileptics.
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 |
|---|---|---|
| Netivudine | 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.
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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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Netivudine and Acyclovir in people with HIV Infections and Chickenpox, run by Glaxo Wellcome at 25 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 5 inclusion and 23 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 25 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.
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?
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.