E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-Infected Patients Evidencing Virologic Suppression Pacientes infectados de VIH, con supresión virológica evidente |
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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 establish the proportion of subjects with virologic rebound (HIV RNA ≥ 400 c/mL) or treatment discontinuation at Week 48 for subjects who received ATV/RTV monotherapy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate in subjects on ATV/RTV monotherapy: • The proportion of subjects with virologic rebound (HIV RNA ≥ 400 c/mL) at Week 48. • The time to treatment failure defined as the earlier of virologic rebound or treatment discontinuation. • The time to virologic rebound. • The changes in CD4 cell counts from baseline through Week 48. • Safety of maintenance treatment with ATV/RTV monotherapy. • The incidence of resistance to ATV/RTV used as single enhanced protease inhibitor therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Provide written informed consent and is capable of reading and comprehending the informed consent 2) On continued antiretroviral treatment, with no discontinuation periods, for the previous 6 months. 3) Absence of evidence or suspected virological failure while receiving any previous antiretroviral therapy. 4) Absence of known primary mutations in the protease gene. 5) Subjects must have received only one HAART regimen prior to the current ATV one. Prior changes in the nucleoside backbone are allowed but subjects may not have experienced confirmed virological failure. In patients with prior NNRTI exposure, a well documented history ensuring no evidence of resistance development to that family is required. No previous sub-optimal therapies (mono or bi-therapies) will be allowed. 6) It has been confirmed that in the 6 months prior to inclusion in the study the viral loads have been below 50 copies/mL. 7) On antiretroviral treatment and no treatment-limiting adverse effects with ATV/RTV + 2 nucleoside reverse transcriptase inhibitors (or 1 Nuc + TDF) for at least 8 weeks before the study entry. 8) Men and women, ages 18 or older 9) Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to REYATAZ SmPC (See protocol appendix 2).
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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) WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone). See protocol Appendix 2. 3) Women who are pregnant or breastfeeding. 4) Women with a positive pregnancy test on enrollment or prior to study drug administration. 5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. 6) Active disease condition which includes: − Moderate to severe hepatic impairment − Active renal disease − History of clinically significant heart conduction disease. 7) 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. 8) Patients with chronic hepatitis B receiving 3TC, TDF or FTC. 9) CD4 cell count below 100 cells/mm3. 10) Serum glucose > 500 mg/dL, 11) Sodium serum levels below 115 meq/L and less or above 165 meq/L and Potassium serum levels below 2 meq/L or above 7 meq/L, 12) Liver enzymes (AST, ALT) > 10 times the upper limit of normal, 13) Hemoglobin < 6.5 g/dL, WBC<800/mm3, absolute neutrophil count < 500/mm3, platelets < 20,000/mm3 or diffuse petechiae. 14) Hypersensitivity to any component of the formulation of study drug. 15) The patient will require any of the drugs contraindicated with ATV/RTV. Refer to Protocol Section 6.4.1. 16) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements. 17) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects with virologic rebound (HIV RNA ≥ 400 c/mL) or treatment discontinuation at Week 48. |
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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 |
GEEMA Questionnaire & plasma samples for resistance analysis in case of virological failure |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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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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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |