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Home > "C" Clinical Trials Conditions > Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients  Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
For Condition: HIV Infections,Chickenpox
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Medication for concurrent conditions (e.g., insulin, antihypertensives, bronchodilators, digoxin) or antibacterials or antifungals to treat concurrent infections at other sites or superinfection of the zoster lesion. - Anti-inflammatory, analgesic (including narcotic analgesic), or antipyretic agents. - Antidepressants and antipsychotics such as amitriptyline and/or fluphenazine. - Nerve blocks. - AZT, ddI, ddC, and amantadine. - Low-dose corticosteroids for treatment of an underlying (not zoster-related) disease. - Immune modulators without varicella-zoster virus activity (e.g., GM-CSF, gp160 vaccine). Patients must have: - HIV infection. - Localized, cutaneous herpes zoster (shingles). - Zoster-associated rash present for 3 or fewer days prior to entry. Prior Medication: Allowed: - Zidovudine. - ddI. - ddC. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Chickenpox. - Evidence of visceral dissemination (organ involvement, i.e., brain, liver, or lung) and/or cutaneous dissemination (more than 20 vesicles in dermatomes beyond contiguous dermatomes) of zoster. - Zoster-like lesion caused by organism other than VZV (e.g., HSV, enterovirus, or Mycoplasma). - Bacterial superinfection of zoster lesion. - Zosteriform lesion previously treated with topical antiviral agents. - Acute, life-threatening opportunistic infection requiring treatment (ongoing suppressive or prophylactic maintenance therapy other than ganciclovir or foscarnet is permitted). - Concurrent severe disease that may either impair ability to take oral medication in capsule or tablet form or limit survival during the 10-day treatment period or during acute phase follow-up (28 days). - Suspected acute deterioration of renal or hepatic function. - Mental impairment that precludes ability to comply with protocol. - Any condition that would render the patient unsuitable for treatment. Concurrent Medication: Excluded during acute phase of study: - Antiviral medications other than AZT, ddI, ddC, or anti-Parkinson's drugs (i.e., amantadine). - Interferon. - Isoprinosine. - Levamisole. - Transfer factor. - Topical virucidal agents, oxidizing agents, DMSO, cell division-stimulating/healing agents, or astringents. - Topical anesthetics (such as capsaicin or xylocaine). - Topical creams or ointments that may interfere with evaluation of zoster lesions. - Cimetidine. - Fluorouracil or its derivatives, flucytosine, or cyclophosphamide (during drug administration and for 2 weeks thereafter). - High-dose corticosteroids. - Anticoagulant therapy (heparin locks and low-dose warfarin sodium permitted). - Probenecid or derivatives. - Treatment for any acute, life-threatening opportunistic infection (suppressive or prophylactic maintenance therapy other than ganciclovir or foscarnet is permitted). Use of the following drugs is discouraged during the long-term phase of the study: - Antiviral agents with VZV activity. - Immunomodulators with presumed VZV activity. - VZV immune globulin. - Capsaicin. - Cimetidine. Patients with the following prior conditions are excluded: - History of immediate hypersensitivity or serum sickness reaction or idiosyncratic reaction (such as hepatic necrosis or Stevens-Johnson syndrome) to any nucleoside analog antiviral agent or to any anticancer therapy with cytolytic agents. Prior Medication: Excluded within 1 month prior to entry: - Any investigational drugs or treatments not licensed for any indication (other than ddI or ddC). Excluded within 2 weeks prior to entry: - Any systemic antiviral therapy, including ganciclovir, foscarnet, vidarabine, acyclovir, or ribavirin. - Any antiretroviral drug other than zidovudine, ddI, and ddC. - Immune globulin (e.g., IgG, VZIG). Excluded within 72 hours prior to entry: - Cyclophosphamide. - Flucytosine. - Fluorouracil or its derivatives. Alcohol or drug abuse.
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
CrumpackerC, Study Chair,
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 53213
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
United States
Univ Dermatology Associates
Cincinnati, Ohio, 452670523
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Washington
Seattle, Washington, 98104
United States
Massachusetts Gen Hosp / Harvard Med School
Boston, Massachusetts, 02114
United States
Washington Univ
St. Louis, Missouri, 63108
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, 96816
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Ohio State Univ / ACTU-Univ Clinic
Columbus, Ohio, 43210
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205
United States
Natl Institutes of Health / NIAID
Bethesda, Maryland, 20892
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28204
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
UCLA Med Ctr
Los Angeles, California, 90095
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Virginia Clinical Research Inc
Norfolk, Virginia, 23507
United States
Infectious Disease Med Group
Oakland, California, 94609
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Salem Veterans Administration Med Ctr
Salem, Virginia, 24153
United States
Dayton Veterans Administration Med Ctr
Dayton, Ohio, 45428
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Univ of New Mexico
Albuquerque, New Mexico, 87131
United States
Veterans Administration Med Ctr / Community AIDS Program
Washington D.C., District of Columbia, 20422
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881
United States
San Diego Naval Hosp
San Diego, California, 92134
United States
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, 13210
United States
Scott and White Hosp
Temple, Texas, 76508
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Veterans Administration Med Ctr
Martinez, California, 94553
United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 11794
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: ACTG 169; Protocol -38/-022
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000953
Other Hiv Infections Studies:
1. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
2. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules
3. The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
4. Continuing Care and Treatment for Patients with Cancer/AIDS/Skin Disease
5. Depot Disulfiram for AIDS and ARC
Related Studies:
Other HIV Infections Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
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