Phase 2 open-label study of MIV-210 in antiretroviral treatment experienced HIV-1 infected subjects
- Conditions
- HIV-1 infection
- Registration Number
- EUCTR2005-001738-34-GB
- Lead Sponsor
- Medivir AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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 ß-human chorionic gonadotropin, ß-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method