SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00193947

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT00193947 Drug Resistance


Primary Outcomes

Measure: 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: during viral suppression

Secondary Outcomes

Measure: to determine whether ARV resistance emerges when pregnant women discontinue ARV

Time: 6 months after drug discontinutation or until viral rebound

Time Perspective: Prospective

Cohort


There are 2 SNPs

SNPs


1 K103N

The K103N was the most common mutation. --- K103N ---

Similarly, the K103N resistance mutation was detected 6 weeks after Nevirapine administration in 3/15 (20%) women in the HIVNET006 phase I/II trial. --- K103N ---


2 Y181C

In contrast to the mothers, the Y181C was the most commonly detected. --- Y181C ---



HPO Nodes