Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
HIV Infections, Chickenpox
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Herpes Zoster, Acyclovir, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine
Eligibility 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.
Sites / Locations
- Univ of Alabama at Birmingham
- Univ of Southern California / LA County USC Med Ctr
- UCLA Med Ctr
- Veterans Administration Med Ctr
- Infectious Disease Med Group
- San Diego Naval Hosp
- Mount Zion Med Ctr
- Univ of Colorado Health Sciences Ctr
- George Washington Univ Med Ctr
- Veterans Administration Med Ctr / Community AIDS Program
- Med College of Georgia
- Univ of Hawaii / Leahi Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Johns Hopkins Hosp
- Natl Institutes of Health / NIAID
- Massachusetts Gen Hosp / Harvard Med School
- Beth Israel Hosp
- Brigham and Women's Hosp
- New England Deaconess Hosp
- Washington Univ
- Univ of New Mexico
- Beth Israel Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- SUNY / Health Sciences Ctr at Stony Brook
- SUNY / Health Sciences Ctr at Syracuse
- Carolinas Med Ctr
- Univ Dermatology Associates
- Ohio State Univ / ACTU-Univ Clinic
- Dayton Veterans Administration Med Ctr
- Med College of Ohio
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Dallas Veterans Administration Med Ctr
- Univ of Texas, Southwestern Med Ctr of Dallas
- Univ TX Galveston Med Branch
- Baylor College of Medicine
- Univ TX San Antonio Health Science Ctr
- Scott and White Hosp
- Univ of Virginia Health Sciences Ctr
- Virginia Clinical Research Inc
- Salem Veterans Administration Med Ctr
- Univ of Washington
- Great Lakes Hemophilia Foundation