- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161434
A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sexually transmitted diseases and genital ulcer disease (GUD) contribute significantly to the spread of HIV, as their presence is associated with higher rates of HIV acquisition in susceptible individuals. Herpes simplex virus-2 (HSV-2) is a major cause of GUD in developed and developing countries.
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.
This study is a randomized, double-blind, placebo-controlled, crossover trial. Sixty men who have sex with men (MSM) will be randomized to first receive either valacyclovir, 1 gram once a day, or matching placebo for 8 weeks. After a 2-week washout period during which all participants receive placebo, subjects then switch to the other treatment for the next 8 weeks.
At screening, informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination. At enrollment, oral, genital, and rectal specimens are obtained and additional blood is drawn. Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary. Following enrollment, they are asked to collect daily home oral and genital samples, as well as semen samples twice a week, for the full 18 weeks of the study. Participants return to the clinic three times per week for follow-up, for collection of oral and rectal specimens, and additional study medication. Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98122
- Virology Research Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV seropositive and HSV-2 seropositive
- MSM (men having sex with men)
- 18 years old or older
Exclusion Criteria:
- Known history of adverse reaction to acyclovir or valacyclovir
- Planned open label use of acyclovir, valacyclovir or famciclovir
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1 gram daily for 8 weeks
Other Names:
|
Placebo Comparator: 2
|
matching placebo for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.
Time Frame: 18 weeks
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To quantify increase in rectal and pharyngeal HIV-1 shedding associated with HSV-1 and HSV-2 reactivation. To determine reduction in systemic HIV RNA during valacyclovir therapy. To evaluate reduction in inflammatory cells and HIV replication.
Time Frame: 18 weeks
|
18 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-6505-A
- P01AI030731 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on valacyclovir
-
Candel Therapeutics, Inc.Active, not recruitingProstate CancerUnited States, Puerto Rico
-
Radboud University Medical CenterCompletedBioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir (VALID-I)Varicella Zoster Virus Infection | Herpes Simplex Virus InfectionNetherlands
-
Dr. Reddy's Laboratories LimitedCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
GlaxoSmithKlineCompletedHerpes LabialisUnited States
-
University of MinnesotaCompletedEpstein-Barr Virus Infections | Cytomegalovirus Infections | Transplantation InfectionUnited States
-
Bristol-Myers SquibbCompletedHerpes Zoster | Shingles
-
National Institute of Allergy and Infectious Diseases...Glaxo WellcomeWithdrawnHIV Infections | Herpes Simplex | Chickenpox
-
GlaxoSmithKlineTerminatedHerpes GenitalisUnited States, Australia, Hong Kong
-
Yung Shin Pharm. Ind. Co., Ltd.CompletedHerpes ZosterTaiwan