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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000953 |
To compare the efficacy of oral sorivudine (brovavir) and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients.
HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.
Condition | Intervention | Phase |
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HIV Infections Chickenpox |
Drug: Sorivudine Drug: Acyclovir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Evaluation of Brovavir ( BV-Ara-U; SQ 32,756 ) Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients |
Estimated Enrollment: | 180 |
HIV-infected patients are at high risk for herpesvirus infections, including varicella-zoster virus ( VZV ) infections, also called shingles. Acyclovir, an approved drug, is widely used to treat VZV infections in the HIV population. Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients, a study is needed to test the relative efficacy of brovavir, an experimental antiviral drug, versus that of acyclovir.
One hundred-eighty patients are randomized to receive either brovavir or acyclovir as follows: brovavir or its matching placebo once daily and acyclovir or its matching placebo five times daily. Treatment continues for 10 days. Entry into the study must occur within 72 hours of lesion development. Patients are followed in person daily or at regular intervals during study drug administration and on days 14, 21, and 28, and then monthly by telephone for 11 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Concurrent Medication:
Excluded during acute phase of study:
Use of the following drugs is discouraged during the long-term phase of the study:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 1 month prior to entry:
Excluded within 2 weeks prior to entry:
Excluded within 72 hours prior to entry:
Alcohol or drug abuse.
Study Chair: | Crumpacker C |
Study ID Numbers: | ACTG 169, Protocol -38/-022 |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000953 |
Health Authority: | United States: Federal Government |
Herpes Zoster Acyclovir Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents sorivudine |
Herpes Zoster Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Chickenpox AIDS-Related Complex Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
Acyclovir HIV Infections Sexually Transmitted Diseases DNA Virus Infections Chicken pox Retroviridae Infections Sorivudine |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses |
Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |