E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
The primary objective is to assess the effects of 14 days of daily dosing of MIV-210 on viral load. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess safety and tolerability of 14 days of daily dosing of MIV-210, and to assess pharmacokinetic parameters of FLG in HIV-1 infected subjects. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Documented HIV-1 infection 2. Adult male and female subjects between the ages 18 and 65 years with or without current ART. 3. No change in ART (or ART interruption) for 12 weeks prior to inclusion. 4. Plasma HIV RNA level ≥ 5,000 copies/mL at 2 to 6 months prior to the baseline visit and at the screening visit, 2 to 4 weeks prior to the baseline visit. 5.Stable HIV-1 infection, defined by stable viral load within ± 0.75 log10 units and plasma HIV RNA values ≤ 75,000 copies/mL for subjects on current ART and plasma HIV RNA values ≤ 750,000 copies/mL for subjects without ART at 2 to 6 months prior to the baseline visit and at the screening visit. 6. Subjects without current ART must have received such treatment within one year of the screening visit. 7. CD4 count > 50/mm3 at the screening visit. 8. The following laboratory parameters at Day-28 to -14 (screening visit):
Absolute neutrophil count >1500/mm3 Leukocytes (total WBC count) >3000/mm3 Platelets >100 000/mm3 Haemoglobin >10 g/dL Creatinine <1.0x the upper limit of normal ASAT and ALAT ≤ 2.5x the upper limit of normal Serum bilirubin < 1.5x the upper limit of normal Serum amylase < 1.25x the upper limit of normal Negative for HbsAg and anti-HCV antibodies Negative for blood and protein in urine
9. Women of child-bearing potential must have a negative pregnancy test (serum or urine β-human chorionic gonadotropin, β-HCG). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study must use a medically acceptable form of contraception. 10. In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits. 11. Subject is capable of understanding and signing an informed consent form.
|
|
E.4 | Principal exclusion criteria |
1. Women who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. 2. Use of an investigational drug within 30 days prior to the study. 3. Initiation of any drug known to affect liver function within 2 weeks of the screening visit. 4. Initiation of any drug known to affect kidney function within 2 weeks of the screening visit. 5. Opportunistic infections within 3 months prior to screening visit. 6. Use of anti-tumoral chemotherapy within 3 months of the screening visit. 7. Use of indinavir within 3 months of the screening visit. 8. Use of recombinant erythropoietin. 9. Use of continuous therapy with acyclovir in dose above 400 mg bid or non-steriodal anti-inflammatory drugs (NSAIDs). 10. Transfusion-dependent subjects and subjects who have received a blood transfusion within 7 days of the screening visit. 11. Renal insufficiency, chronic or ongoing hepatitis pancreatitis.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in plasma HIV RNA over the treatment period of 14 days. |
|
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 | 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) | 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 | No |
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 | No |
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 | No |
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
|
Last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |