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A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients Clinical research trials and A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients clinical trial. Participants frequently get the best healthcare available for their A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients  A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).
Details: Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have the following: - HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes. - Signed the consent form or present a signed parental consent form if below 18 years. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy. Patients with the following are excluded: - Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. - History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy. Prior Medication: Excluded: - Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.
Total Enrollment:
Location and Contact Information:
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39216
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670560
United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
United States
West Haven Veterans Administration Med Ctr
West Haven, Connecticut, 06516
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908
United States
Louisiana State Univ Med School
New Orleans, Louisiana, 701122822
United States
Denver Public Health Dept / Disease Control Services
Denver, Colorado, 80204
United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Vanderbilt School of Medicine
Nashville, Tennessee, 37232
United States
Northwestern Memorial Hosp
Chicago, Illinois, 60611
United States
Univ of South Florida
Tampa, Florida, 33612
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
ViRx Inc
San Francisco, California, 94103
United States
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
United States
Additional Information:
Study ID Numbers: 104A; 08
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002000
Other Herpes Simplex Studies:
1. A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)
2. A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
3. A Comparison of Two Anti-HIV Treatment Plans
4. A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
5. Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
Related Studies:
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A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
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