Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals? (VALIDATE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00860977 |
|
Recruitment Status :
Completed
First Posted : March 13, 2009
Last Update Posted : March 6, 2018
|
Sponsor:
University Health Network, Toronto
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
University Health Network, Toronto
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infection Herpes Simplex Type II HIV Infections | Drug: valacyclovir Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 202 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | VALacyclovir In Delaying Antiretroviral Treatment Entry |
| Actual Study Start Date : | March 2010 |
| Actual Primary Completion Date : | August 2015 |
| Actual Study Completion Date : | August 2015 |
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Placebo
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
|
Drug: Placebo
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily |
|
Experimental: Valacyclovir
oral valacyclovir 500mg twice daily
|
Drug: valacyclovir
oral valacyclovir 500mg twice daily
Other Name: Valtrex |
Primary Outcome Measures :
- annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time. [ Time Frame: up to 5 years ]
Secondary Outcome Measures :
- time from baseline until reaching the composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first. [ Time Frame: up to 5 years ]
- Annual rate of change in the CD4 cell count percentage, calculated as the slope of the participants' CD4 count percentage change over time [ Time Frame: up to 5 years ]
- Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up [ Time Frame: up to 5 years ]
- Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine) [ Time Frame: up to 5 years ]
- Frequency of episodes of HSV reactivations at any anatomic site [ Time Frame: up to 5 years ]
- Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV [ Time Frame: up to 5 years ]
- Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point [ Time Frame: up to 5 years ]
Other Outcome Measures:
- analysis of inflammatory markers in HIV disease progression, HIV Resistance Mutations and other herpesvirus serologies [ Time Frame: up to 6 years ]
- genetic testing of HLA-B*5701 and HLA-B*5703 status, and future genetic markers related to HIV disease progression and the impact of herpes and valacyclovir [ Time Frame: up to 5 years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult (aged 18 years or older or as per Local/Provincial Guidelines)
- documented HIV-1 infection (determined by EIA and Western blot, sites' standard assays are acceptable if approved in advance by the PIs for the study, Dr. Darrell Tan and/or Dr. Sharon Walmsley)
- no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
- antiretroviral naïve (no more than 14 days of total prior ARV exposure)
- CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 30 days of initiating trial (baseline visit)
- does not meet recommendations for initiating ARV therapy according to current guidelines
Exclusion Criteria:
- pregnancy or actively planning to become pregnant
- receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
- Estimated creatinine clearance <30 mL/min
- Other medical condition likely to cause death within 24 months
- Enrolled in a therapeutic HIV vaccine or immunotherapy trial
- Enrolled in another trial investigating the impact of another intervention on HIV disease progression
- HIV elite controller (EC), phenotypically defined here as documented duration of HIV infection of ≥5 years, a persistent CD4 cell count ≥500 cells/mm3, and a persistent plasma HIV viral load of <1000 copies/mL in the absence of antiretroviral therapy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860977
Locations
Show 25 study locations
Sponsors and Collaborators
University Health Network, Toronto
CIHR Canadian HIV Trials Network
Investigators
| Principal Investigator: | Sharon L Walmsley, MD FRCPC MSc | University Health Network, Toronto | |
| Principal Investigator: | Darrell HS Tan, MD FRCPC | University Health Network, Toronto |
Additional Information:
Publications:
Publications:
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00860977 |
| Other Study ID Numbers: |
CTN 240 ISRCTN66756285 |
| First Posted: | March 13, 2009 Key Record Dates |
| Last Update Posted: | March 6, 2018 |
| Last Verified: | March 2018 |
Keywords provided by University Health Network, Toronto:
|
HIV Herpes simplex virus type II Genital herpes Treatment Naive |
Additional relevant MeSH terms:
|
Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Valacyclovir Antiviral Agents Anti-Infective Agents |