Status:
COMPLETED
The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance
Lead Sponsor:
Radboud University Medical Center
Conditions:
HIV-infection
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this two-phase trial is as follows: * To determine the elimination half-life of NVP in HIV positive pregnant women receiving it as a single dose in labour in addition to the ...
Detailed Description
This trial (VITA2) will be done with phenytoin as enzyme inducer to decrease the elimination half-life of NVP as it has also shown a significant difference in the elimination half-life of NVP in the E...
Eligibility Criteria
Inclusion
- HIV-infected as documented by positive HIV antibody test
- Antiretroviral naïve
- Starting ARV prophylaxis from 28th weeks of gestation or at least 4 weeks before delivery
- Not intending to relocate out of the area for the duration of study participation
- Willingness of subject to adhere to follow up schedule (note: this is more intensive for the pilot PK phase)
- Ability and willingness of subject to give written consent
- Pregnant women aged 18 years and above
- Willing and able to regularly attend the antenatal clinic
Exclusion
- Serious illness that requires systemic treatment or hospitalization
- Use of concomitant medication, which interferes with the ARV prophylaxis for PMTCT or phenytoin
- Any condition that in the opinion of the investigator would compromise the subjects' ability to participate in the study
- Previously treated for HIV infection with antiretroviral agents, including ARV prophylaxis for PMTCT
- Inability to understand the nature and extent of the trial and the procedures required
- CD4 count \<350 cells/µl because such a patient is eligible for HAART
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01187719
Start Date
May 1 2010
End Date
September 1 2012
Last Update
December 1 2020
Active Locations (2)
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1
Kilimanjaro Christian Medical Centre
Moshi, Kilimanjaro, Tanzania
2
University Teaching Hospital
Lusaka, Zambia