An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy |
- 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 ] [ Designated as safety issue: No ]
- to determine whether ARV resistance emerges when pregnant women discontinue ARV [ Time Frame: 6 months after drug discontinutation or until viral rebound ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | November 2003 |
| Study Completion Date: | May 2008 |
| Groups/Cohorts |
|---|
| women initiating ARV therapy during pregnancy with neveripine |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women attending the UHN immunodeficiency clinic
Inclusion Criteria: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 Criteria:
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Contacts and Locations| Canada, Ontario | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Principal Investigator: | Sharon Walsmley | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | University Health Network Toronto, university health network |
| ClinicalTrials.gov Identifier: | NCT00193947 History of Changes |
| Other Study ID Numbers: | 03-0162-B |
| Study First Received: | September 15, 2005 |
| Last Updated: | August 2, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013