E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020180 |
E.1.2 | Term | HIV positive |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) HIV antibody positive 2) 18 years and over 3) pregnant 4) Tolerating a lopinavir/ritonavir based regimen in pregnancy
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E.4 | Principal exclusion criteria |
1) Less than 18 years of age 2) Taking medication known to interfere with lopinavir 3) Unable to give informed consent
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |