Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: generic lopinavir/ritonavir

Study type

Interventional

Funder types

Other

Identifiers

NCT00621166

HIV-NAT 093

approved

Details and patient eligibility

About

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 safety of generic lopinavir/ritonavir® Compare pharmacokinetics parameters before and after pregnancy.

Full 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 (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 adequate levels of lopinavir/ritonavir, we will record 12-hour PK at third trimester. Second trimester and post-partum 12-hour PK are optional. Furthermore, we will collect safety and efficacy throughout the study.

Enrollment

20 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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