E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
• To compare the pharmacokinetic profile of saquinavir at steady state in HIV-infected patients taking saquinavir/ritonavir 1000/100 mg with two different meals (low-fat and high-fat meals) |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety and tolerability of saquinavir/ritonavir 1000/100 mg bid in HIV-infected patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements 2. Male or non-pregnant, non-lactating females 3. Between 18 to 65 years, inclusive 4. Documented HIV-1 infection and plasma HIV RNA at screening visit below 400 copies/mL. (Note retesting of screening viral load is allowed) 5. Receiving a stable antiretroviral regimen that includes saquinavir/ritonavir and two or more nucleos(t)ide reverse transcriptase inhibitors (NRTIs) for at least two weeks before the screening 6. Agrees not to change saquinavir/ritonavir regimen from screening until the end of the treatment period (except for the dose change in saquinavir/ritonavir as described in the Protocol), unless this is medically indicated as decided by the treating physician
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E.4 | Principal exclusion criteria |
. Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic disorders or malignancy 2. Have a body mass index (BMI) >35 3. Presence of any current active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: • Stable cutaneous Kaposi's Sarcoma 4. Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study 5. Concurrent non-nucleoside reverse transcriptase inhibitor (NNRTI) use 6. Concurrent protease inhibitors apart from the use of ritonavir at doses less than or equal to 100 mg twice daily 7. The use of disallowed concomitant therapy (see concomitant medication and treatment, section 5.2) 8. Females of childbearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period 9. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial 10. Subjects with clinical or laboratory evidence of significantly decreased hepatic function
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma concentrations of saquinavir and ritonavir during administration with a low-fat and a high-fat containing meal |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
High fat meal versus low fat meal |
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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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |