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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00193947 |
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Date of registration:
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15/09/2005 |
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Primary sponsor: |
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Public title:
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An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy
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Scientific title:
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An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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56 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00193947 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sharon Walsmley |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Key inclusion & exclusion criteria
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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.
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Exclusion Criteria:
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Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Drug Resistance
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Primary Outcome(s)
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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.
[Time Frame: during viral suppression]
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Secondary Outcome(s)
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to determine whether ARV resistance emerges when pregnant women discontinue ARV
[Time Frame: 6 months after drug discontinutation or until viral rebound]
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Secondary ID(s)
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03-0162-B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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