E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Human Immunodeficiency Virus (HIV-1) infection |
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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 | PT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
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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 |
To compare the immunologic changes with different treatment approaches after HAART discontinuation. |
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E.2.2 | Secondary objectives of the trial |
•To assess the time-weighted average change from baseline through 24 and 48 weeks ( DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with plasma HIV-1 RNA >50 copies/mL at baseline
•To assess the time-weighted average change from 4 weeks through 24 and 48 weeks ( DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with <50 copies/mL at baseline
•To assess the proportion of patients with HIV RNA <400 and <50 copies/mL at 4 weeks for subjects with plasma HIV-1 RNA <50 copies/mL at baseline
•To compare log10 plasma HIV-1 RNA at week 4 for patients with HIV-RNA < 50 copies/mL at baseline.
•To monitor the safety profile of each arm, recording all adverse events that may appear during the study.
•To define the new resistance profile 24 and 48 weeks after the HAART discontinuations.
•To assess changes in patient quality of life
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive PCR for HIV-1 RNA. •Adult patients (over 18 years of age). •Available genotype (current or historical) showing M184V and (≥ 2 TAMs or K65R) •CD4 cell count ≥350 cells/mL •Patient request to stop HAART due to any of the following:
1) Patient is receiving a suppressive HAART regimen but has problems with adherence, quality of life or toxicity AND there is no alternative simpler, less toxic regimen (typically patients with substantial resistance and good virological control while receiving multiple antiretrovirals). 2) Due to resistance, patient is receiving a non-suppressive HAART regimen but patient is not willing to change to a new, already available, more complicated optimized salvage regimen (typically 3rd or 4th line of therapy).
•For women of childbearing potential, negative urine pregnancy test at screening visit. •Agreement to take part in the study and sign the informed consent.
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E.4 | Principal exclusion criteria |
•Patients receiving a non-registered antiretroviral (ARV) drug. •Patients who have < 50 HIV-RNA copies/mL while receiving an NNRTI. •Serum HBsAg positive and patient is receiving an anti-HBV active nucleoside/nucleotide. •Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of these drugs. •Known history of drug abuse or chronic alcohol consumption that in clinician opinion contraindicates participation in the study •Women who are pregnant or breast feeding or females of childbearing potential who do not use an adequate method of contraception according to the investigator’s judgment. •Current active opportunistic infection or documented infection within the previous 4 weeks. •Documented active malignant disease (excluding Kaposi sarcoma limited to the skin). •Renal disease with creatinine clearance < 50 mL/min. •Concomitant use of nephrotoxic or immuno-suppressive drugs (should be stopped prior to enrollment) •Receiving on-going therapy with systemic corticosteroids, Interleukin-2 (IL-2) or chemotherapy. •Patients who are not to be included in the study according to the investigator’s criterion.
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare CD4 cell loses 24 weeks after HAART discontinuation |
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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 | 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 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 | 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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |