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Pharmacokinetics Study on Nevirapine Resistance in Tanzania

NCT ID: NCT00294892

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV mother to child transmission; MTCT nevirapine resistance pharmacokinetics Treatment Naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbamazepine

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

Group Type ACTIVE_COMPARATOR

carbamazepine and nevirapine

Intervention Type DRUG

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

Nevirapine

Standard therapy of 200mg Nevirapine oral prior to delivery

Group Type PLACEBO_COMPARATOR

Nevirapine

Intervention Type DRUG

Nevirapine 200mg is taken prior to delivery during labor.

Interventions

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carbamazepine and nevirapine

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

Intervention Type DRUG

Nevirapine

Nevirapine 200mg is taken prior to delivery during labor.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M. Burger, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University (RUNMC)

Locations

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Kilimanjaro Christian Medical College

Moshi, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 22134145 (View on PubMed)

Related Links

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http://journals.lww.com/jaids/Abstract/2012/03010/Intrapartum_Single_Dose_Carbamazepine_Reduces.7.aspx

J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention.

Other Identifiers

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VITA1

Identifier Type: -

Identifier Source: org_study_id