Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir
Condition: Herpes Simplex; HIV Infections
MeSH terms: Infections; Communicable Diseases; Herpes Simplex; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS
      patients who have herpes simplex virus infections that are resistant to standard treatment
      with acyclovir.

      Foscarnet is a drug that inhibits viruses and has been shown to be effective against
      infection with Cytomegalovirus and also against infection with the Herpes simplex virus in
      several patients with AIDS. Vidarabine has been shown to have activity against the Herpes
      simplex virus in patients who do not have AIDS, but it has not been studied in patients who
      do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who
      have herpes simplex infection that has not responded to therapy with acyclovir in the hope
      that one of these two drugs will help to stop further progression of the herpes simplex
      infection and may have fewer side effects.
    

Detailed description: 
      Foscarnet is a drug that inhibits viruses and has been shown to be effective against
      infection with Cytomegalovirus and also against infection with the Herpes simplex virus in
      several patients with AIDS. Vidarabine has been shown to have activity against the Herpes
      simplex virus in patients who do not have AIDS, but it has not been studied in patients who
      do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who
      have herpes simplex infection that has not responded to therapy with acyclovir in the hope
      that one of these two drugs will help to stop further progression of the herpes simplex
      infection and may have fewer side effects.

      Following evaluation studies, patients receive at least 10 days of intravenous (IV) therapy
      with acyclovir. During this therapy, patients have two serum concentration levels of
      acyclovir drawn to make sure there are adequate levels of medication in their blood. If skin
      lesions do not heal after a total of 10 days of therapy with acyclovir, lesions are swabbed
      for viral culture to test the susceptibility of the virus to therapy with acyclovir,
      foscarnet, and vidarabine. If the test confirms that the herpes lesions are resistant to
      acyclovir, patients may choose to participate in the next phase of the study. Following
      additional evaluation studies, patients are randomized to one of two groups, each of which
      receives 10-21 days of IV treatment with one of the two alternative medications, foscarnet or
      vidarabine. Foscarnet is given by IV infusion every 8 hours, and each infusion lasts 1 hour.
      Vidarabine is given by IV infusion once a day, and each infusion lasts 12 hours. While
      receiving therapy with either foscarnet or vidarabine, blood tests are done every 3 days for
      routine lab tests and once a week to determine foscarnet or vidarabine blood levels. Skin
      lesions are cultured for herpes virus every 5 days. At the end of 10 days of therapy,
      improvement is evaluated, and the patients can continue to receive therapy if indicated.
      There is a provision for cross-over treatment if patients show a poor response.
    

Intervention name(s): Vidarabine; Acyclovir; Foscarnet sodium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Acyclovir; Foscarnet; Phosphonoacetic Acid; Vidarabine
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Vidarabine; Phosphonoacetic Acid; Herpes Simplex; Foscarnet; Acyclovir; Acquired Immunodeficiency Syndrome