An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy
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|ClinicalTrials.gov Identifier: NCT00193947|
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : August 3, 2011
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.
|Condition or disease||Phase|
|Drug Resistance||Phase 4|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||56 participants|
|Official Title:||An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy|
|Study Start Date :||November 2003|
|Study Completion Date :||May 2008|
|women initiating ARV therapy during pregnancy with neveripine|
- 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 ]
- to determine whether ARV resistance emerges when pregnant women discontinue ARV [ Time Frame: 6 months after drug discontinutation or until viral rebound ]
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): NCT00193947
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Sharon Walsmley||University Health Network, Toronto|