Status:
TERMINATED
An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy
Lead Sponsor:
University Health Network, Toronto
Conditions:
Drug Resistance
Eligibility:
FEMALE
18+ years
Brief Summary
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 load...
Detailed Description
The HIVNET 012 clinical trial demonstrates a cost effective strategy to prevent maternal fetal transmission of HIV. In this study, a single 200 mg dose of Nevirapine was given to pregnant Ugandan wome...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Objective 1)
- HIV infected adults
- Antiretroviral naïve
- Viral load \>1000 copies/ml
- Initiating combination antiretroviral therapy, which includes nevirapine.
- Exclusion Criteria (Objective 1)
- 1\. Women with CD4 counts \> 250/mm3
- Inclusion Criteria (Objective 2)
- HIV infected adults
- On their initial ARV combination which contains nevirapine
- HIV RNA \< 50 copies/ml
- Decision to discontinue ARV therapy at the completion of pregnancy or for a drug holiday
- 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
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Key Trial Info
Start Date :
November 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00193947
Start Date
November 1 2003
End Date
May 1 2008
Last Update
August 3 2011
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4