Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000953
First received: November 2, 1999
Last updated: February 25, 2011
Last verified: February 2011
  Purpose

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
HIV Infections
Chickenpox
Drug: Sorivudine
Drug: Acyclovir
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 180
Primary Completion Date: September 1996 (Final data collection date for primary outcome measure)
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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000953

  Show 44 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Glaxo Wellcome
Investigators
Study Chair: Crumpacker C
  More Information

Additional Information:
Publications:
Gnann J, et al. Sorivudine (BV-araU) versus acyclovir for Herpes zoster in HIV-infected patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:55

ClinicalTrials.gov Identifier: NCT00000953     History of Changes
Other Study ID Numbers: ACTG 169, Protocol -38/-022
Study First Received: November 2, 1999
Last Updated: February 25, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Herpes Zoster
Acyclovir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
sorivudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chickenpox
Herpes Zoster
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Acyclovir
Sorivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014