Pharmacokinetics Study on Nevirapine Resistance in Tanzania

November 26, 2020 updated by: Radboud University Medical Center

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbamazepine
An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery
Drug: carbamazepine and nevirapine
Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
Placebo Comparator: Nevirapine
Standard therapy of 200mg Nevirapine oral prior to delivery
Drug: Nevirapine
Nevirapine 200mg is taken prior to delivery during labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cord blood will be taken less than 30 minutes after delivery
Time Frame: 0 - 30 min after delivery
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
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
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
0 30 min after delivery - week 3 after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: David M. Burger, Dr., Radboud University (RUNMC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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