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| Sponsored by: |
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
Show 25 Study Locations
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 Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Chickenpox AIDS-Related Complex Antiviral Agents Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Acyclovir HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
|
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 |