Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women

Launched by THE HIV NETHERLANDS AUSTRALIA THAILAND RESEARCH COLLABORATION · Feb 21, 2008

Keywords

ClinConnect Summary

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 (ARV) are independently associated with decreased transmission\[1\]. With a HAART regimen the transmission rate can be reduced till under the 2 %\[1, 2\]. Possibly suitable drugs which can be used during pregnancy is lopinavir/ritonavir based regimens. In Thailand, aluvir is not available therefore a generic lopinavir/ritonavir tablet formulation will be used in our study.

In order to prove ade...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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