Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects

ApoPharma

Status and phase: Completed; Phase 1

Conditions: Asymptomatic HIV Infection

Treatments: Drug: Intravenous deferiprone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456558

LA44-0114

Details and patient eligibility

About

This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Intravenous deferiprone, 1.5 g

Experimental group

Description:

Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily

Treatment:

Drug: Intravenous deferiprone

Intravenous deferiprone, 2 g

Experimental group

Description:

Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily

Treatment:

Drug: Intravenous deferiprone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo