Status:
COMPLETED
Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Conditions:
HIV Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To investigate the possible influence of pregnancy and duration of pregnancy To determine the antiviral activity and saf...
Detailed Description
HAART in pregnant HIV-infected serves two goals, preventing mother to child transmission and providing adequate treatment for the mother. Levels of HIV RNA at delivery and the use of antiretrovirals (...
Eligibility Criteria
Inclusion
- Documented positive test for HIV-1 infection
- Subject is at least 18 and not older than 40 years of age at the day of the first dosing of study medication
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Pregnant for a maximum of 30 weeks at the day of first dosing of study medication
Exclusion
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the trial and the procedures required.
- Abnormal serum transaminases or creatinine, determined as levels being \> 3 times upper limit of normal.
- Concomitant use of medications that interfere with Generic lopinavir/ritonavir pharmacokinetics
- Active hepatobiliary or hepatic disease (N.B. chronic hepatitis B/C co-infection is allowed)
- Documented previous virological failure of a lopinavir/ritonavir containing regimen or documented resistance to lopinavir/ritonavir prior to dosing
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00621166
Start Date
June 1 2008
End Date
December 1 2009
Last Update
July 17 2020
Active Locations (1)
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1
Department of Obsterics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330