Can Valaciclovir delay the need for initiation of human immunodeficiency virus (HIV) treatment in HIV – infected individuals
- Conditions
- Herpes simplex virus type 2 (HSV-2) and human immunodeficiency virus type 1 (HIV-1) co-infectionInfections and InfestationsHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
- Registration Number
- ISRCTN66756285
- Lead Sponsor
- niversity Health Network (UHN) (Canada)
- Brief Summary
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21106086 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30376108 (16/04/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 230
Current inclusion criteria as of 17/12/2012:
1. Adult (aged 18 years or older or as per Local/Provincial Guidelines), either sex, with documented HIV-1 infection
2. Documented HIV-1 infection (determined by EIA and Western blot)
3. No use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
4. Anti-retroviral naive (no more than 14 days of total prior anti-retroviral [ARV] exposure)
5. 5.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)
6. Does not meet recommendations for initiating ARV therapy according to current guidelines
Initial inclusion criteria at the time of registration:
1. Adults aged over 18 years, either sex, with documented HIV-1 infection
2. Documented HSV-2 seropositivity
3. Maximum of two episodes recurrent symptomatic HSV recurrences per year by self-report
4. Neither currently using nor anticipated to require chronic anti-HSV therapy during the study
5. Anti-retroviral naive (no more than 14 days of total prior anti-retroviral [ARV] exposure)
6. CD4 count within the 400 - 900 cells/mm^3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial
7. Does not meet recommendations for initiating ARV therapy according to current guidelines
Current exclusion criteria as of 17/12/2012:
1. Pregnant or actively planning to become pregnant
2. Receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
3. Have an estimated creatinine clearance less than 30 ml/min
4. Have another medical condition likely to cause death within 24 months
5. Enrolled in a therapeutic HIV vaccine or immunotherapy trial
6. Enrolled in another trial investigating the impact of another intervention on HIV disease progression
7. 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
Initial exclusion criteria at the time of registration:
1. Pregnant
2. Receiving chemotherapy or chronic steroid therapy
3. Have an estimated creatinine clearance less than 30 ml/min
4. Have an active opportunistic infection
5. Have another medical condition likely to cause death within 24 months
6. Enrolled in a therapeutic vaccine or immunotherapy trial
7. Enrolled in another trial investigating the impact of another intervention on HIV disease progression
8. Fit the phenotype of an HIV elite controller (EC), since the natural history of HIV infection is fundamentally different in such individuals
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method