E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of HIV infection |
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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 |
1. To document the safety and feasibility of topical plasmid DNA immunization 2. To investigate if topical immunization with DNA plasmids carrying HIV genes during cycles of effective HAART can reduce the viral load when HAART is interrupted. 3. To study the effect on CD4 counts i the three groups
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E.2.2 | Secondary objectives of the trial |
1. To correlate the viral load after the third STI to immune responses at that time 2. To investigate if hydroxyurea increases the efficacy of topical immunization. 3. To characterize the new HIV specific immune responses by Elispot and other single cell methods 4. To investigate the possible viral escape mutants in relation to the induced immune responses 5. To study the individual experience and quality of life of the patients during repeated cycles of STIs combined with immunizations
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Aged between 18 and 60 years 2. HIV infection detected by two serological and/or HIV plasma RNA tests 3. On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months 4. Current CD4 count above 400 5. CD4 count nadir >200 6. Viral isolate pre ART available is a preferable but not mandatory 7. Willing to consider stopping HAART repeatedly. 8. Willing to conform to a low alcohol intake (maximum of one glas per day) 9. Able to tolerate didanosine and hydroxyurea 10. Willing to change their HAART to exclude NNRTI and stavudine 11. Able to give informed consent 12. Availability for follow-up for planned duration of the study
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E.4 | Principal exclusion criteria |
1. Pregnancy 2. Patients with ongoing infection(s) other than HIV. 3. Prior or current panceatitis or history of alcohol abuse. 4. Ongoing neuropathy and history of more than grade 1 neuropathy. 5. History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure. 6. Sun or solarium exposure at the immunizing sites one month before or during the trial. 7. Cortisone treatment, systemic or local at the immunizing sites, one month beforte or during the trial. 8. Patients with signs of autoimmune diseases 9. Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ml, platelets <150,000/ml and LFT > 5x upper limit of normal 10. Patients on any immune modulating or investigational drug 11. Anamnestic allergy to kanamycin, plasmid gene products
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Grade 3 or above toxicity possibly or probably related to the immunization or hydroxyurea. 2. Viral load at week 33 compared between groups or with baseline. 3. CD4 slope between groups or optionally time to reach CD4 of 350
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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 | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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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Each patient is studied for 33 weeks with an optional extension to week 81. The recruitment period is expected to be 6 months. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |