HIV-1 infection
Conditions
Interventions
Product Name: MIV-210
Pharmaceutical Form: Capsule, hard
Current Sponsor code: MIV-210 hemisulphate salt
Other descriptive name: MSS-157, GSK204937A
Sponsors
Medivir AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effects of 14 days of daily dosing of MIV-210 on viral load.;Secondary Objective: 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.;Primary end point(s): Change in plasma HIV RNA over the treatment period of 14 days. | — |
Countries
United Kingdom
Outcome results
None listed