Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00005663
Other study ID # 104C
Secondary ID HS230018
Status Active, not recruiting
Phase Phase 3
First received May 11, 2000
Last updated June 23, 2005
Start date June 1999

Study information

Verified date July 2001
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Valacyclovir hydrochloride


Locations

Country Name City State
Canada Dr Barbara Romanowski Edmonton Alberta
Canada Clinique Medicale L'Actuele Montreal Quebec
Canada Centre De Recherche En Infectiologie Ste Foy Quebec
Canada Sunnybrook Health Science Ctr Toronto Ontario
United States IDC Research Initiative Altamonte Springs Florida
United States East Bay AIDS Ctr Berkeley California
United States Pacific Oaks Research Beverly Hills California
United States Nalle Clinic / Clinical Research Dept Charlotte North Carolina
United States Healthnet Institute Fort Lauderdale Florida
United States Advanced Biomedical Research Inc Hackensack New Jersey
United States Baylor College of Medicine / Dept of Medicine Houston Texas
United States Indiana Univ School of Medicine / Dept of Infect Dis Indianapolis Indiana
United States Kraus Med Partners Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Univ of Minnesota Minneapolis Minnesota
United States Philadelphia FIGHT Philadelphia Pennsylvania
United States Westover Heights Clinic Portland Oregon
United States Dr Alvan Fisher Providence Rhode Island
United States Wake County Dept of Health Raleigh North Carolina
United States Richmond AIDS Consortium Richmond Virginia
United States ViRx Inc San Francisco California
United States Univ of Washington Virology Research Clinic Seattle Washington
United States Treasure Coast Infectious Disease Consultants Vero Beach Florida
United States Palm Beach Research Ctr West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Canada, 

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2