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Sponsors and Collaborators: |
Canadian HIV Trials Network Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz |
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Information provided by: | Canadian HIV Trials Network |
ClinicalTrials.gov Identifier: | NCT00860977 |
The purpose of this study is to determine whether medication to suppress herpes simplex virus type 2 (HSV-2) infection can slow the rate of HIV disease progression and delay the need for initiating HAART in HIV, HSV-2 co-infected individuals.
Condition | Intervention | Phase |
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HIV Infection Herpesvirus 2, Human HIV Infections |
Drug: valacyclovir Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | VALacyclovir In Delaying Antiretroviral Treatment Entry |
Estimated Enrollment: | 480 |
Study Start Date: | September 2009 |
Estimated Study Completion Date: | August 2014 |
Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
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Drug: Placebo
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
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Valacyclovir: Experimental
oral valacyclovir 500mg twice daily
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Drug: valacyclovir
oral valacyclovir 500mg twice daily
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Highly active antiretroviral therapy (HAART) has drastically reduced the morbidity and mortality associated with HIV infection, and transformed HIV from an invariably fatal disease into a manageable, chronic condition.
However, the inconvenience, high cost, potential side effects, and significant risk of developing drug-resistant HIV associated with taking daily, lifelong HAART make the potential delay of HAART initiation an extremely desirable goal for HIV-infected individuals.
Suppression of herpes simplex virus (HSV)-2 co-infection may provide a novel therapeutic strategy for achieving this goal. HSV-2 is among the most common co-infections seen in persons infected with HIV, with rates of up to 52-95%. This co-infection is associated with increased blood levels of HIV, a major predictor of HIV disease progression, even when the person has no herpes symptoms. Medications such as valacyclovir that suppress herpes can also decrease blood levels of HIV, but the potential long-term clinical benefits of this drug have not been adequately studied. It is thus hypothesized that valacyclovir could slow HIV disease progression and prolong the period of time before a co-infected person needs to initiate HAART. This research has been designed to answer this important question through a randomized, placebo-controlled, multi-centre clinical trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon L Walmsley, MD FRCPC MSc | 416-340-4800 ext 3871 | sharon.walmsley@uhn.on.ca |
Contact: Darrell HS Tan, MD FRCPC | 416-340-4800 ext 2240 | darrell.tan@gmail.com |
Brazil | |
Instituto de Pesquisa Clínica Evandro Chagas | |
Rio de Janeiro, Brazil | |
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2N2 |
Principal Investigator: | Sharon L Walmsley, MD FRCPC MSc | University Health Network, Toronto |
Principal Investigator: | Darrell HS Tan, MD FRCPC | University Health Network, Toronto |
Responsible Party: | CIHR Canadian HIV Trials Network ( Dr Sharon Walmsley, Dr Darrell Tan ) |
Study ID Numbers: | CTN-240, ISRCTN66756285 |
Study First Received: | March 11, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00860977 History of Changes |
Health Authority: | Canada: Health Canada |
HIV Herpes simplex virus type 2 Genital herpes Treatment Naive |
Herpes Simplex Anti-Infective Agents Sexually Transmitted Diseases, Viral Skin Diseases Herpes Genitalis Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes |
Herpesviridae Infections Valacyclovir Virus Diseases Skin Diseases, Infectious HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Herpes Simplex Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Herpesviridae Infections Valacyclovir Skin Diseases, Viral Virus Diseases Skin Diseases, Infectious HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |