NCT00294892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Feb 2006

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

February 21, 2006

Last Update Submit

November 26, 2020

Conditions

HIV Infections

Keywords

HIVmother to child transmission; MTCTnevirapine resistancepharmacokineticsTreatment Naive

Outcome Measures

Primary Outcomes (4)

  • Cord blood will be taken less than 30 minutes 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.

    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)

    day 6 - 22 after delivery

  • From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns.

    0 30 min after delivery - week 3 after delivery

Study Arms (2)

Carbamazepine

ACTIVE COMPARATOR

An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery

Drug: carbamazepine and nevirapine

Nevirapine

PLACEBO COMPARATOR

Standard therapy of 200mg Nevirapine oral prior to delivery

Drug: Nevirapine

Interventions

carbamazepine and nevirapineDRUG

Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.

Carbamazepine
NevirapineDRUG

Nevirapine 200mg is taken prior to delivery during labor.

Nevirapine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Christian Medical College

Moshi, Tanzania

Location

Related Publications (1)

  • 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.

    PMID: 22134145DERIVED

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

CarbamazepineNevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • David M. Burger, Dr.

    Radboud University (RUNMC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

February 1, 2006

Primary Completion

September 1, 2009

Study Completion

June 1, 2010

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

TA(1)