E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pacientes con infección de VIH-1 (Patients with HIV-1 infection). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000807 |
E.1.2 | Term | Acute 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 |
Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs (peripheral blood mononuclear cells). |
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E.2.2 | Secondary objectives of the trial |
· Decay of residual HIV-1 replication under RAL intensification (an ultrasensitive RT-PCR assay with a lower limit of quantification of 3 copies/ml is going to be used) · Effect of RAL intensification on the frequency of blips during the study (>50 copies/mL, preceeded and followed by determinations <50 copies/mL in previous and posterior controls).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. HIV-1 infected adults (³18 years old). 2. Absence of prior virological failure. 3. No mono or dual NRTI therapy previous to HAART initiation. 4. Complete virological suppression (<50 copies/mL) for ³ 12 months, including at least 3 times during the last year. 5. Patients on their first HAART regimen including a PI or an NNRTI and at least two nucleos/tide inhibitors. Patients may have changed their HAART due to intolerance or toxicity but not because of treatment failure. VL must have been suppressed below 50 copies/mL during the change. 6. CD4 cell count ≥400 cells/µL. 7. Voluntary written informed consent.
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E.4 | Principal exclusion criteria |
1. Pregnancy, or fertile women willing to be pregnant. 2. Active substance abuse or major psychiatric disease. 3. Presence of drug-related mutations or any polymorphism or mutation associated to RAL resistance prior to first HAART (only if genotype is available).
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E.5 End points |
E.5.1 | Primary end point(s) |
Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | 1 |
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 | 1 |
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 |