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

NCT00193947 | Terminated

• 1 other identifier: 03-0162-B
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Drug Resistance

Outcome Measures

Primary Outcomes (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.

  during viral suppression

Secondary Outcomes (1)

• to determine whether ARV resistance emerges when pregnant women discontinue ARV

  6 months after drug discontinutation or until viral rebound

Study Arms (1)

women initiating ARV therapy during pregnancy with neveripine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women attending the UHN immunodeficiency clinic

You may qualify if:

• HIV infected adults
• Antiretroviral naïve
• Viral load \>1000 copies/ml
• Initiating combination antiretroviral therapy, which includes nevirapine.

You may not qualify if:

• \. Women with CD4 counts \> 250/mm3
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Sharon Walsmley

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 19, 2005
• Study Start: November 1, 2003
• Study Completion: May 1, 2008
• Last Updated: August 3, 2011

Record last verified: 2007-04

Locations

CA (1)