E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of HIV infection |
|
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 investigate the mechanism(s) by which Nevirapine increases plasma HDL concentration.
To evaluate the effect of increased HDL on endothelial function as a surrogate endpoint for cardiovascular disease. |
|
E.2.2 | Secondary objectives of the trial |
The percentage change of fractional synthethic rate (FSR) of APO A-1 from week 0 (baseline) to 24 weeks of treatment with NVP-based antiretroviral therapy.
The percentage change in plasma levels of lipoproteins in the fasting lipid panel from week 0 (baseline) to 6 weeks and at 24 weeks of treatment with NVP-based antiretroviral therapy.
The percent change in activity (and/or mass) of the constituents of the lipid enzymes panel at 6 and 24 weeks of NVP-based antiretroviral therapy. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
18 years of age or older Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening Patients with HIV-1-RNA< or equal 50 copies/ml documented on at least two occasions within 6 months prior to enrollment Documentation of plasma HIV-1-RNA< or equal 50 copies/ml for> or equal 6 months while on Trizivir without other ARV. Ability and willingness to complete the study |
|
E.4 | Principal exclusion criteria |
Previous exposure to NNRTI drugs documented diabetes mellitus Hypertension fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl) use of lipid-lowering medication during the 90 days prior study enrollment chronic active hepatitis B and/or C Anemia active opportunistic infection or neoplasm within 3 months prior to screening Any history of CV disease Hepatic, renal or thyroid abnormalities Pregnancy or lactation Active anticoagulation therapy History of HIV-2 infection Active alcohol/drug abuse ALT/AST > 2.5 x ULN Total Bilirubin > 2 x ULN Use of anabolic steroids during the 90 days prior to study enrollment Patients on any therapy for which a stable regimen has not been achieved for at least 28 days prior to visit 2 Female patients with CD4 counts >250 cells/mm3 Male patients with CD 4 counts >400 cells/mm3 Patients taking and unable to discontinue any of the restricted drugs: - Any investigational agent - All lipid regulating agents (e.g. high dose niacin, fibrates, bile acid sequestering resins, HMG-CoA reductase inhibitors, psyllium derivatives or fish oil) - Azole antifungal agents (IV/oral) - Macrolides - Rifampicin, rifabutin - St. Johns Wort - Antihypertensive medication with known effects on the vascular endothelium (e.g. calcium channel blockers, ACE inhibitors) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The percentage change of fractional synthetic rate (FSR) of apo A-I from week 0 (baseline) to 6 weeks of treatment with NVP-based antiretroviral therapy.
The percentage change of flow mediated dilatation (FMD) from week 0 (baseline) to 6 and 24 weeks of treatment with NVP-based antiretroviral therapy. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.6 | Cross over | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
|
as defined in the protocol |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 9 |