E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 infected, clinically stable with not AIDS defining events
|
|
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 evaluate and compare for each dose group of 5mg, 10mg, 20mg and 40mg of HDP 99.0003:
- The safety and tolerability of 14 days dosing
- The antiretroviral efficacy of 14 days dosing |
|
E.2.2 | Secondary objectives of the trial |
- To assess pharmacokinetics at each dose group
- To define the dose with the best benefit risk ratio for further clinical development |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- HIV-1 infection documented by licensed HIV antibody ELISA and confirmed either by Western blot, positive HIV blood culture, positive HIV serum p24 antigen or plasma HIV-1 viremia
- No evidence of resistance to antiretroviral agents in a genotypic resistance test
- Plasma HIV-1 RNA load between 5.000 c/mL and 250.000 c/mL
- CD4+ T-cell count > 200 cells/mm3
- No prior AIDS-defining diagnosis (category C of the CDC classification)
- Antiretroviral treatment naïve, defined as less than 6 weeks of prior treatment with antiretroviral agents more than 3 months ago
- Males or non-lactating non-pregnant females
- Females of childbearing potential must have a negative urine pregnancy test at screening and prior to initial dosing on Day 1
- subjects of 18 years of age or older
- Able and willing to provide written informed consent |
|
E.4 | Principal exclusion criteria |
- Evidence of HIV-2 infection
- Evidence for chronic HBV and/or HCV infection
- Patients with acute HIV-1 infection
- Patients with the following laboratory parameters within 30 days prior to first dose of study drug: hemoglobin <7.0 mmol/L, neutrophil count <1000/mm3, platelet count <75,000/mm3, AST or ALT >2.5 times the upper limit of normal, amylase > 1.5 times the upper limit of normal, estimated creatinine clearance of <50 mL/min (using the Cockcroft formula)
- Patients with malabsorption syndromes affecting drug absorption (e.g., Crohn's disease, chronic pancreatitis)
- Patients enrolled in other investigational protocols or studies within the last 3 months
- Patients who have taken any prescribed medications within three weeks before the first dose of study drug, except for oral contraceptives by women and incidental use of analgesics
- History of alcohol or drug abuse within 6 months of the study
- Current or relevant previous history of serious, severe, or unstable (acute, or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures
- Patients who are, in the opinion of the investigator, unable to comply with the dosing schedule and protocol evaluations |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Recording adverse events at the different doses of HDP 99.0003
- Change in plasma HIV-1 RNA levels from baseline to day 14. |
|
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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | No |
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 | 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 |
|
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
|
Last visit at day 30 (± 2 days) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |