Status:
COMPLETED
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Lead Sponsor:
Radboud University Medical Center
Conditions:
HIV Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00294892
Start Date
February 1 2006
End Date
June 1 2010
Last Update
November 30 2020
Active Locations (1)
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1
Kilimanjaro Christian Medical College
Moshi, Tanzania