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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002315 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Chickenpox |
Drug: Netivudine Drug: Acyclovir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients |
| Estimated Enrollment: | 400 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of intolerance, hypersensitivity, or severe drug reaction to acyclovir.
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| SORRA / NC Research Ctr | |
| Birmingham, Alabama, United States, 35234 | |
| Simon - Williamson Clinic | |
| Birmingham, Alabama, United States, 35211 | |
| United States, Arizona | |
| Univ of Arizona / Univ Med Ctr | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Saint Francis Mem Hosp | |
| San Francisco, California, United States, 94109 | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| Sunnyvale Med Clinic | |
| Sunnyvale, California, United States, 94086 | |
| United States, Connecticut | |
| Clinical Research Consultants | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Iowa | |
| Med Associates Clinic | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Louisiana | |
| Oschner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Missouri | |
| Washington Univ | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Mexico | |
| New Mexico Med Group | |
| Albuquerque, New Mexico, United States, 87110 | |
| United States, North Carolina | |
| Jordon Diagnostics and Research Inc | |
| High Point, North Carolina, United States, 27262 | |
| Hanover Med Specialists | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 97201 | |
| Oregon Research Group | |
| Eugene, Oregon, United States, 97401 | |
| United States, Rhode Island | |
| Roger Williams Med Ctr | |
| Providence, Rhode Island, United States, 02908 | |
| Silver Lake Med Inc | |
| Providence, Rhode Island, United States, 02909 | |
| United States, Tennessee | |
| Vanderbilt Med Ctr | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| N Texas Ctr for AIDS & Clin Rsch | |
| Dallas, Texas, United States, 75219 | |
| MacGregor Med Association | |
| Houston, Texas, United States, 77054 | |
| Univ TX Med Branch | |
| Nassau Bay, Texas, United States, 77058 | |
| United States, Washington | |
| Infections Ltd / Physicians Med Ctr | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Rhinelander Med Ctr | |
| Rhinelander, Wisconsin, United States, 54501 | |
| Med Consultants LTD | |
| Milwaukee, Wisconsin, United States, 53215 | |
More Information
| Study ID Numbers: | 130A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002315 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Herpes Zoster Acyclovir Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
|
Herpes Zoster Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Chickenpox Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Acyclovir HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |