Status:
COMPLETED
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Bristol-Myers Squibb
Glaxo Wellcome
Conditions:
HIV Infections
Chickenpox
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 i...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00000953
Last Update
March 1 2011
Active Locations (44)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
3
UCLA Med Ctr
Los Angeles, California, United States, 90095
4
Veterans Administration Med Ctr
Martinez, California, United States, 94553