Status:
COMPLETED
Antiretroviral Drug Levels During and After Pregnancy
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Northwestern University
Conditions:
Pharmacokinetics
Eligibility:
FEMALE
18-39 years
Brief Summary
In HIV-infected women, the use of combination therapy with antiretrovirals (ARV) in pregnancy prevents HIV related morbidity and mortality and prevents mother-to-child transmission of the HIV virus. ...
Detailed Description
In HIV-infected women, the use of combination therapy with antiretrovirals (ARV) in pregnancy prevents HIV related morbidity and mortality and prevents mother-to-child transmission of the HIV virus.1 ...
Eligibility Criteria
Inclusion
- HIV-infected pregnant female in her second or third trimester who requires ARV therapy during her pregnancy
- Antiretroviral therapy includes nevirapine in addition to two NRTI agents
- Informed consent obtained
Exclusion
- If primary physician feels the required blood draws would be potentially dangerous to the patient or fetus
- Haemoglobin \<8 g/dL
- Liver Function tests \> 2x normal
- CD4 cell count \>250 cells/mL if ART naive
- Calculated Creatinine Clearance \< 30 ml/min at any visit during the study period
- Patients receiving any medications that may interact with the cytochrome p450 enzyme system metabolism of nevirapine
- Concurrent herbal medication use.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00616252
Start Date
February 1 2008
End Date
September 1 2009
Last Update
December 6 2010
Active Locations (1)
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1
Infectious Diseases Institute, Faculty of Medicine, Makerere University
Kampala, Kampala, Uganda, 22418