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A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients Clinical research trials and A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients. A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients  A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
For Condition: HIV Infections,Herpes Genitalis,Herpes Simplex
Status: No longer recruiting
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
Details: Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 18 years old. - Are HIV-positive. - Have herpes simplex virus (HSV) 2. - Have received combination anti-HIV therapy for at least 2 months before entering the study. - Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.) - Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.) Exclusion Criteria Patients will not be eligible for this study if they: - Have blood vessel disease. - Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir. - Are unable to take medications by mouth. - Have non-healed sores on the anus or genitals at beginning of study. - Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary. - Are using interferon. Patients receiving interferon must stop interferon before beginning the study. - Have kidney or liver problems. - Are pregnant or breast-feeding. - Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.
Total Enrollment:
Location and Contact Information:
Healthnet Institute
Ft. Lauderdale, Florida, 33316
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
ViRx Inc
San Francisco, California, 94109
United States
Univ of Washington Virology Research Clinic
Seattle, Washington, 98122
United States
Pacific Oaks Research
Beverly Hills, California, 90211
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Advanced Biomedical Research Inc
Hackensack, New Jersey, 07601
United States
Dr Alvan Fisher
Providence, Rhode Island, 02907
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Kraus Med Partners
Los Angeles, California, 90036
United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498
United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
United States
Dr Barbara Romanowski
Edmonton, Alberta,
Canada
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, 46202
United States
Wake County Dept of Health
Raleigh, North Carolina, 27610
United States
Palm Beach Research Ctr
West Palm Beach, Florida, 33409
United States
Westover Heights Clinic
Portland, Oregon, 97210
United States
Clinique Medicale L'Actuele
Montreal, Quebec,
Canada
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Centre De Recherche En Infectiologie
Ste Foy, Quebec,
Canada
Sunnybrook Health Science Ctr
Toronto, Ontario,
Canada
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Additional Information:
Study ID Numbers: 104C; HS230018
Study Start Date: June 1999
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005663
Other Hiv Infections Studies:
1. Analysis of Immune Responses to HIV Vaccines
2. The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients
3. A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy
4. Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
5. Comparison of ddI Versus Zidovudine in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
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