A study of the pharmacokinetics of new formulation lopinavir/ritonavir in the genital tract and plasma of HIV infected women in pregnancy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006297-23-GB

Enrollment

Registered

2009-01-12

Start date

2007-06-12

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV during pregnancy MedDRA version: 8.1 Level: LLT Classification code 10020180 Term: HIV positive

Interventions

Trade Name: Kaletra tablets Product Name: Kaletra 200mg/50mg film coated tablets Product Code: NA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Lopinavir Concentration unit: mg/g millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) HIV antibody positive 2) 18 years and over 3) pregnant 4) Tolerating a lopinavir/ritonavir based regimen in pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Less than 18 years of age 2) Taking medication known to interfere with lopinavir 3) Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess levels of lopinavir in blood and the genital tract in HIV infected pregnant women in the third trimester using the new lopinavir/ritonavir formulation, Kaletra, at standard dosing. ;Secondary Objective: The secondary objective is to correlate genital tract and blood lopinavir levels with the HIV viral load in both compartments. When measuring lopinavir levels both total and free levels will be measured to determine the impact of altered protein binding, associated with the physiological changes of pregnancy, on free lopinavir levels.;Primary end point(s): 1) the total lopinavir levels in the plasma and female genital tract. 2) HIV-viral load in the plasma and female genital tract 3) Free lopinavir levels lopinavir/ritonavir If lopinavir is unable to get into the female genital tract it will not be able to exert its antiviral effect and this may be reflected in poor virological response within this compartment. Incomplete virological control in the female genital tract may increase the risk for vertical transmission of HIV, particularly as more women are now opting for a vaginal delivery. Furthermore incomplete virological control increases the risk of developing antiretroviral resistance. Previous work from this unit demonstrated that whilst there was generally good correlation between the HIV viral loads in the plasma and genital tract there was significant genetic diversity between the 2 compartments. Poor penetration of antiretroviral drugs into the female genital tract may explain this phenomenon and may have implications for vertical and horizontal transmission of resistant HIV. By assessing the steady state pharmacokinetics of the new formulatoin of lopinavir/ritonavir in the plasma and genital tract in HIV infected women in pregnancy will provide important information for the continued care of HIV infected women in pregnancy.	—

Measure

Time frame

Main Objective: The primary objective is to assess levels of lopinavir in blood and the genital tract in HIV infected pregnant women in the third trimester using the new lopinavir/ritonavir formulation, Kaletra, at standard dosing. ;Secondary Objective: The secondary objective is to correlate genital tract and blood lopinavir levels with the HIV viral load in both compartments. When measuring lopinavir levels both total and free levels will be measured to determine the impact of altered protein binding, associated with the physiological changes of pregnancy, on free lopinavir levels.;Primary end point(s): 1) the total lopinavir levels in the plasma and female genital tract. 2) HIV-viral load in the plasma and female genital tract 3) Free lopinavir levels lopinavir/ritonavir If lopinavir is unable to get into the female genital tract it will not be able to exert its antiviral effect and this may be reflected in poor virological response within this compartment. Incomplete virological control in the female genital tract may increase the risk for vertical transmission of HIV, particularly as more women are now opting for a vaginal delivery. Furthermore incomplete virological control increases the risk of developing antiretroviral resistance. Previous work from this unit demonstrated that whilst there was generally good correlation between the HIV viral loads in the plasma and genital tract there was significant genetic diversity between the 2 compartments. Poor penetration of antiretroviral drugs into the female genital tract may explain this phenomenon and may have implications for vertical and horizontal transmission of resistant HIV. By assessing the steady state pharmacokinetics of the new formulatoin of lopinavir/ritonavir in the plasma and genital tract in HIV infected women in pregnancy will provide important information for the continued care of HIV infected women in pregnancy.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026