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 proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load on an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.
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E.2.2 | Secondary objectives of the trial |
Assess for Maintenance Phase •proportion of subjects with HIV RNA viral load <400 c/mL through Week 48 •time to treatment failure •changes from baseline in CD4 cell count through Week 48 •changes from baseline in fasting lipid parameters through Week 48 •safety of switching to ATV containing regimen versus remaining on ATV/RTV containing HAART regimen Describe for Induction Phase •efficacy & safety of ATV/RTV containing HAART regimen used for treatment induction, for randomized & non-randomized subjects •changes from baseline in CD4 cell count •changes in other exploratory immunological markers (e.g., CD8 cell count, CD45 RA/CD4, CD45 RO/CD4, CD45 RA/CD8 & CD45 RO/CD8 ratios) during treatment induction with ATV/RTV
Sec. obj. in subjects without undetectable viral load after treatment induction with ATV/RTV for 26 to 30 weeks & continuing treatment with ATV/RTV containing HAART regimen, will be to describe efficacy & safety of continuing ATV/RTV containing HAART regimen
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Written informed consent 2) Treatment naïve HIV-1 infected subjects ( < 10 days of treatment with any ARV). 3) Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening. 4) Subjects who have a CD4 count ≥ 50 cells/mm3. 5) Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate). 6) Both females of child-bearing potential and males must utilize effective barrier contraception. |
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E.4 | Principal exclusion criteria |
1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study. 2) Women who are pregnant or breastfeeding 3) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment 4) Primary HIV infection 5) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis 6) Screening laboratory values measured as follows: a) Grade IV glucose, b) Grade IV electrolytes, c) Grade IV transaminases, d) Grade IV hematology. 7) Hypersensitivity to any component of the formulation of study drug 8) Prior history of taking any ARV for more than 10 days 9) Concomitant administration of tenofovir (TDF). 10) Any other clinical conditions or prior therapy that, in the opinion of the investigator and/or according to the Reyataz SmPC or any other local prescribing information for Reyataz (if more restrictive than the Reyataz SmPC), would make the subject unsuitable for study or unable to comply with the dosing requirements. 11) Prisoners or subjects who are compulsorily detained |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint measure will be the proportion of subjects with viral load < 50 c/mL through Week 48 of the Maintenance Phase between the 2 treatment arms.
Secondary Endpoint Measures: • The proportions of subjects with an HIV-1 RNA viral load < 400 c/mL through the Maintenance Phase. • The time to treatment failure during the Maintenance Phase, defined as confirmed viral load (≥ 50 c/mL and ≥ 400 c/mL) or study withdrawal. • The time to first occurrence of confirmed HIV-1 RNA viral load < 50 c/mL (and < 400 c/mL) during the study. • The changes from baseline in CD4 cell count through the Induction, and Maintenance and Rescue Phases. • The changes from baseline in HIV-1 RNA through the Induction and Rescue Phases. • The treatment outcome at the end of the Rescue Phase. • The changes from baseline in fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides through the Induction and Maintenance Phases. • The frequency and severity of adverse events, of laboratory abnormalities and of discontinuations for adverse events during the Induction and Maintenance Phases. • The frequency of serious adverse events and of discontinuations for adverse events during the Rescue Phase.
Exploratory Endpoint Measure: • The changes from baseline in other immunological markers (e.g., CD8 cell counts, CD45 RA/CD4, CD45 RO/CD4, CD45 RA/CD8 and CD45 RO/CD8 ratios) through the Induction Phase.
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |