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Pharmacokinetics Study on Nevirapine Resistance in Tanzania

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ClinicalTrials.gov Identifier: NCT00294892
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE February 21, 2006
First Posted Date  ICMJE February 22, 2006
Last Update Posted Date May 31, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2007)
  • Cord blood will be taken less than 30 minutes after delivery [ Time Frame: 0 - 30 min after delivery ]
  • Blood samples from mother will be taken less than 30 minutes after delivery to measure viral load and CD4 count. [ Time Frame: 0 - 30 min after delivery ]
  • Blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22) [ Time Frame: day 6 - 22 after delivery ]
  • From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns. [ Time Frame: 0 30 min after delivery - week 3 after delivery ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2006)
  • * cord blood will be taken less than 30 minutes after delivery
  • * blood samples from mother and child will be taken less than 30 minutes after delivery to measure viral load and CD4 count.
  • * blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22)
  • From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns.
Change History Complete list of historical versions of study NCT00294892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Official Title  ICMJE The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)
Brief Summary

Primary

  • pharmacokinetics of single dose nevirapine
  • the effect of single dose carbamazepine on the pk of single dose nevirapine
  • resistance against nevirapine before and after.
  • follow-up on HIV status newborns
  • relation between nevirapine levels in cord blood and plasma

Secondary

* safety of single dose nevirapine and nevirapine/carbamazepine

Hypothesis:

Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.

Detailed Description Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: carbamazepine and nevirapine
    Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
  • Drug: Nevirapine
    Nevirapine 200mg is taken prior to delivery during labor.
Study Arms  ICMJE
  • Active Comparator: Carbamazepine
    An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery
    Intervention: Drug: carbamazepine and nevirapine
  • Placebo Comparator: Nevirapine
    Standard therapy of 200mg Nevirapine oral prior to delivery
    Intervention: Drug: Nevirapine
Publications * Muro EP, Fillekes Q, Kisanga ER, L'homme R, Aitken SC, Mariki G, Van der Ven AJ, Dolmans W, Schuurman R, Walker AS, Gibb DM, Burger DM. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. doi: 10.1097/QAI.0b013e31824234d8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2006)
144
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV infected
  • antiretroviral naive
  • not intending to relocate out of area during study
  • willing to adhere to follow up scheme
  • ability and willing to give written consent
  • pregnant between 18 and 40 years
  • willing and able to regularly attend the Antenatal clinic

Exclusion Criteria:

  • serious illness that requires systemic treatment or hospitalization
  • any condition that would compromise subject's ability to participate
  • previously treated for HIV with antiretroviral agents, including single dose nevirapine used for MTCT
  • inability to understand the nature and extent of the trial and procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00294892
Other Study ID Numbers  ICMJE VITA1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M. Burger, Dr. Radboud University (RUNMC)
PRS Account Radboud University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP