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Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir Clinical research trials and Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir. Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir clinical trial. Subjects frequently get the best healthcare possible for their Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir  Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir
Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir
For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed for phase B: - Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia (PCP). Prior Medication: Allowed for phase A: - Ganciclovir. Patients receiving this drug at the time of study enrollment must discontinue the drug at the time of enrollment and for the duration of the study period. Exclusion Criteria Co-existing Condition: For phase A, patients with pre-existing severe neurologic impairment such as seizure disorder or marked or incapacitating ataxia are excluded. Concurrent Medication: Excluded upon entry into phase B: - Ganciclovir. - Immunomodulators. - Probenecid. - Ciprofloxacin. - Allopurinol. - Zidovudine (AZT). - Antiretrovirals. - Other investigational agents. - Acyclovir for another labeled indication. - Potentially nephrotoxic agents. Patients will be excluded from the study for the following reasons: Phase A: - Previous hypersensitivity reaction to foscarnet or vidarabine. Patients who have a documented history of vidarabine intolerance may be eligible for the foscarnet on the non-randomized arm of the study. Phase B: - Clinical response to therapy with acyclovir in phase A described as "healed" or "good." Prior Medication: Excluded within 14 days of study entry: - Immunomodulators or biologic response modifiers. Phase A: - Excluded within 30 days of study entry: - Foscarnet. Phase B: Excluded within 7 days of study entry into phase B: - Any potentially nephrotoxic agent, except acyclovir. Prior Treatment: Excluded for phase A within 14 days of study entry: - Lymphocyte replacement therapy. Patients must demonstrate the following clinical and laboratory findings: Phase A: - HIV positive by federally licensed ELISA test confirmed by Western blot, p24 serum antigen, or a positive HIV culture; or a prior diagnosis of AIDS as defined by Centers for Disease Control criteria. - Mucocutaneous herpes simplex virus (HSV) infection confirmed by viral culture persisting for a minimum of 2 weeks which is clinically resistant to therapy with acyclovir in the opinion of the patient's physician. Phase B: - Persistent shedding of HSV at the completion of or within 1 week after completion of phase A acyclovir therapy as confirmed by viral culture. Documented in vitro resistance of the virus to acyclovir. - All strains must be referred to the Diagnostic Virology Laboratories at either San Francisco General Hospital or Beth Israel Hospital, Boston, for susceptibility testing. - Two serum acyclovir levels drawn during phase A. Results may be pending at time of entry into phase B. - All eligibility evaluations must be performed within 7 days prior to study entry for phase A or B.
Total Enrollment: 26
Location and Contact Information:
Overall Study Official:
SSafrin, Study Chair,
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of Washington
Seattle, Washington, 98105
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Additional Information:
Study ID Numbers: ACTG 095;
Study Start Date:
Record last reviewed: October 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000985
Other Hiv Infections Studies:
1. Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS)
2. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
3. The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients
4. Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
5. HERPEVAC Trial for Women
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir
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