An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy

This study has been terminated.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00193947
First received: September 15, 2005
Last updated: August 2, 2011
Last verified: April 2007
  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.


Condition Phase
Drug Resistance
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

Women attending the UHN immunodeficiency clinic

Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00193947

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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

ClinicalTrials.gov processed this record on September 29, 2014