E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 (asymptomatic patients) |
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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 monitor tolerability after single IV doses and after a short repeat dose regimen with initial loading doses (to achieve a rapid steady state serum level). |
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E.2.2 | Secondary objectives of the trial |
To determine single dose and repeat dose IV pharmacokinetics. To monitor viraemia after single doses. To determine the dose range associated with a reduction in mean viraemia ³ 0.6 log HIV-1 RNA copies/mL plasma (early Proof of Concept). To monitor duration of any achieved decrease in viraemia. To obtain tolerance data from 4 weeks of repeat dose administration. To apply the loading regimen. To demonstrate the rapid attainment of steady-state. To characterize the serum levels at steady-state. To assess stationarity (i.e. time invariance) after repeat dosing. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1 18-65 year old patients of both sexes. 2 Body weight 50-100 kg at screening. 3 HIV-1 seropositive patients. 4 ≥ 6 months following 1st diagnosis of HIV and below 10 years. 5 Plasma viral load more than or equal to 3,000 - less than or equal to 100,000 copies viral RNA/mL. 6 CD4+ cell count more than or equal to 300/mm3 at two occasions measured 3 months apart. 7 No prior antiretroviral therapy within 6 months of screening. 8 No antiviral drug within 8 weeks of screening. Patients stabilized on Aciclovir and Valaciclovir for more than 6 months may be enrolled. 9 Asymptomatic at screening and Day 0 concerning the HIV-infection. 10 Karnofsky performance status of 90% at screening. 11 If positive screen for HBV or HCV, inclusion allowed if patients have no active infection. If positive screen for both HBV and HCV, alanine aminotranferase (ALT) must be within normal range at screening. 12 Be willing and able to comply with the protocol for the duration of the study including scheduled follow-up visits. 13 Have given written informed consent, prior to screening, with the understanding that consent may be withdrawn at any time without prejudice.
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E.4 | Principal exclusion criteria |
1 Females of childbearing potential must not be enrolled. 2 Other systemic infection than HIV-1 within 6 weeks or vaccination prior to screening or day 0. 3 Autoimmune diseases, Rheumatoid Arthritis or Inflammatory Bowel Disease confirmed by clinical history. 4 Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal at screening. 5 Hemoglobin < 120 g/L (< 110 g/L for women) at screening. 6 Neutrophil counts < 1.0x10-9/L (Africans with a stable count of < 0.6x10-9/L) at screening. 7 Platelet count < 75x10-9/L at screening. 8 Subjects with history or currently active alcohol or drug use which in the Investigator’s opinion, would compromise the subject’s safety and compliance with the study protocol requirements. 9 A positive urine drug screen for opiates, cocaine and amphetamine at two consecutive screenings (a positive drug test at screening will be repeated at baseline). 10 Active cardiovascular treatment. 11 Allergies which could be detrimental according to the Investigator’s opinion. 12 Previous allergic reaction to immunoglobulin. 13 Any disease that might interfere with patient safety or compliance. 14 Participation in a drug study with a new investigational drug within 90 days prior to Day 0. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Drug safety in asymptomatic HIV-1 patients. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
| Yes |
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 | 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 | |
E.8.9.1 | In the Member State concerned days | |