Drug Resistance Clinical Trial
Official title:
An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy
Verified date | April 2007 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
Hypothesis
Nevirapine resistance developed in women and infants in the HIVNET 006 and 012 cohorts as a
consequence of use of an agent with a long t½ as monotherapy in individuals with high viral
loads.
Objective 1 To demonstrate that Nevirapine resistance does not develop in HIV infected
patients when used as part of triple antiretroviral combination therapy between the
initiation of treatment and suppression of HIV RNA to <1000 copies/ml.
Objective 2 To demonstrate that resistance to nevirapine does not develop when patients with
suppressed HIV RNA discontinue combination antiretroviral therapy which contains nevirapine.
Status | Terminated |
Enrollment | 56 |
Est. completion date | May 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria:Inclusion Criteria (Objective 1) 1. HIV infected adults 2. Antiretroviral naïve 3. Viral load >1000 copies/ml 4. Initiating combination antiretroviral therapy, which includes nevirapine. Exclusion Criteria (Objective 1) 1. Women with CD4 counts > 250/mm3 Inclusion Criteria (Objective 2) 1. HIV infected adults 2. On their initial ARV combination which contains nevirapine 3. HIV RNA < 50 copies/ml 4. Decision to discontinue ARV therapy at the completion of pregnancy or for a drug holiday 5. Not resistant to nevirapine. Note that since most patients meeting the criteria for Objective 1 are expected to achieve HIV RNA < 50 copies/mL, the patient populations for Objectives 1 and 2 will be almost the same. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To demonstrate that Nevirapine resistance does not develop in HIV infected patients when used as part of triple antiretroviral combination therapy between the initiation of treatment and suppression of HIV RNA to <1000 copies/ml. | during viral suppression | No | |
Secondary | to determine whether ARV resistance emerges when pregnant women discontinue ARV | 6 months after drug discontinutation or until viral rebound | No |
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