Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects
Phase 1
Completed
- Conditions
- Asymptomatic HIV Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT02456558
- Lead Sponsor
- ApoPharma
- Brief Summary
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
- Detailed Description
This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- HIV-1 positive
- HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen
- HIV-1 RNA > 10,000 copies/mL
- ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range
- Body mass index (BMI) of 18.5 to 30.0 kg/m^2
- Absolute neutrophil count at baseline of ≥1.0 x 10^9/L (black African population only) or ≥1.5 x 10^9/L (all other races)
Exclusion Criteria
- Evidence of AIDS-associated illness, excluding superficial candidiasis
- CD4+ T-cell count of < 350/mm^3
- Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test
- Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies
- History or presence of malignancy
- A serious, unstable chronic illness during the past 3 months before screening
- A serious, unresolved acute illness at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous deferiprone, 1.5 g Intravenous deferiprone Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily Placebo Placebo Subjects in this arm will receive an infusion of placebo twice-daily for 10 days, at a volume equivalent to that of the active product in the respective cohort Intravenous deferiprone, 2 g Intravenous deferiprone Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events Day 1 to Day 56 Change from baseline in level of HIV DNA in peripheral blood mononucleated cells Day 1 to Day 56 Proportion of subjects withdrawn due to the need for rescue medication Day 1 to Day 56 Change from baseline in HIV viral load Day 1 to Day 56 Change from baseline in CD4+ T-cell count Day 1 to Day 56
- Secondary Outcome Measures
Name Time Method The pharmacokinetics parameters of Cmax, Tmax, and AUC0-∞, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose 10-hour interval
Trial Locations
- Locations (2)
VxPharma
🇿🇦Pretoria, South Africa
Phoenix Pharma
🇿🇦Port Elizabeth, Eastern Cape, South Africa